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Hide glossary GLOSSARY Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms * Accepts healthy volunteers A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study. * Active comparator arm An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers. * Adverse event An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied. * Age or age group A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: * Child (birth-17) * Adult (18-64) * Older Adult (65+) * All-cause mortality A measure of all deaths, due to any cause, that occur during a clinical study. * Allocation A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. * Arm A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol. * Arm type A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm. * Baseline characteristics Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment). * Canceled submission Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled. * Certain agreements Information required by the Food and Drug Administration Amendments Act of 2007. In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed. * Certification A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification. * Certification/extension first posted The date on which information about a certification to delay submission of results or an extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the first posted date. * Certification/extension first submitted The date on which the study sponsor or investigator first submitted a certification or an extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov (certification/extension first posted). * Certification/extension first submitted that met QC criteria The date on which the study sponsor or investigator first submitted a certification or an extension request that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed. * City and distance In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the state, identifying "Chicago" as the city and "100 miles" as the distance will find all studies listing a location within 100 miles of Chicago. * Clinical study A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies. * Clinical trial Another name for an interventional study. * ClinicalTrials.gov identifier (NCT number) The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). * Collaborator An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. * Condition/disease The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks. * Contact The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions. * Country In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a state and identifying a city and distance. * Cross-over assignment A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned. * Data Monitoring Committee (DMC) A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB. * Early Phase 1 (formerly listed as Phase 0) A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). * Eligibility criteria The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex. * Enrollment The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study. * Exclusion criteria A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. * Expanded access A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types. For more information, see FDA Expanded Access: Information for Patients. * Expanded access status * Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied. * No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future. * Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future. * Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public. * Expanded access type Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access: * Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation. * Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA. * Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use. * Experimental arm An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial. * Extension request In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information. * Factorial assignment A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants. * FDAAA 801 Violations A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801). The National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. This information is provided by the FDA. There are three categories of information that may be included: * Violation: Shown when the FDA issues a Notice of Noncompliance and posts the Notice of Noncompliance on its designated webpage. There are three types of violations: * Failure to submit required clinical trial information * Submission of false or misleading clinical trial information * Failure to submit primary and secondary outcomes * Correction: Shown when the FDA confirms that the responsible party has updated the study record to correct the violation and posts the correction notice on its designated webpage. Because of the time for FDA review and processing, there may be a delay between the date when the study record was updated and the addition of correction information to the FDAAA 801 Violation information. * Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on its designated webpage. * First posted The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date. * First submitted The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date). * First submitted that met QC criteria The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. * Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study results database. For more information on FDAAA 801, see the History, Policies, and Laws page on this site. * Funder type Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as sponsors and collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders: * U.S. National Institutes of Health * Other U.S. Federal agencies (for example, Food and Drug Administration, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs) * Industry (for example: pharmaceutical and device companies) * All others (including individuals, universities, and community-based organizations) * Gender-based eligibility A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based on a person's self-representation of gender identity. Gender identity refers to a person's own sense of gender, which may or may not be the same as their biological sex. * Group/cohort A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes. * Human subjects protection review board A group of people who review, approve, and monitor the clinical study's protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee. For more information, see Participating in Studies on this site. * Inclusion criteria A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. * Informed consent A process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study. For more information, see Participating in Studies on this site. * Informed consent form (ICF) The document used in the informed consent or process. * Intervention model The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment, parallel assignment, cross-over assignment, and factorial assignment. * Intervention/treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. * Interventional study (clinical trial) A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. * Investigator A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator. * Last update posted The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date. * Last update submitted The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date). * Last update submitted that met QC criteria The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. * Last verified The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown. * Listed location countries Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the last update submitted date; any country for which all facilities were removed from the study record are listed under removed location countries. * Location terms In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations. * Masking A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking. * NCT number A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. * No intervention arm An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial. * Observational study A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study. * Observational study model The general design of the strategy for identifying and following up with participants during an observational study. Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other. * Other adverse event An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above. * Other study IDs Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers. * Other terms In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to study records that contain these words. * Outcome measure For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure. * Parallel assignment A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B. * Participant flow A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort. This includes the number of participants who started, completed, and dropped out of the study. * Patient registry A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world. * Phase The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. * Phase 1 A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. * Phase 2 A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. * Phase 3 A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. * Phase 4 A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. * Phase Not Applicable Describes trials without FDA-defined phases, including trials of devices or behavioral interventions. * Placebo An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied. * Placebo comparator arm An arm type in which a group of participants receives a placebo during a clinical trial. * Primary completion date The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study. * Primary outcome measure In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. * Primary purpose The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other. * Principal investigator (PI) The person who is responsible for the scientific and technical direction of the entire clinical study. * Protocol The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information. * Quality control (QC) review National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations. * Randomized allocation A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. * Recruitment status * Not yet recruiting: The study has not started recruiting participants. * Recruiting: The study is currently recruiting participants. * Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate. * Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. * Suspended: The study has stopped early but may start again. * Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated. * Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred). * Withdrawn: The study stopped early, before enrolling its first participant. * Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years. * Registration The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov. * Removed location countries Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator. * Reporting group A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group. * Responsible party The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator. * Results database A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results "posted." Note: The ClinicalTrials.gov results database became available in September 2008. Older studies are unlikely to have results available in the database. * Results delayed Indicates that the sponsor or investigator submitted a certification or extension request. * Results first posted The date on which summary results information was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay between the date the study sponsor or investigator first submits summary results information (the results first submitted date) and the results first posted date. Some results information may be available at an earlier date if Results First Posted with QC Comments. * Results first posted with QC comments The date on which summary results information was first available on ClinicalTrials.gov with quality control review comments from the National Library of Medicine (NLM) identifying major issues that must be addressed by the sponsor or investigator. As of January 1, 2020, initial results submissions for applicable clinical trials (ACTs) that do not meet quality control review criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Accordingly, the Results First Posted with QC Comments date may be earlier than the Results First Posted date for an ACT with summary results information that is not consistent with NLM quality control review criteria. * Results first submitted The date on which the study sponsor or investigator first submits a study record with summary results information. There is typically a delay between the results first submitted date and when summary results information becomes available on ClinicalTrials.gov (the results first posted date). * Results first submitted that met QC criteria The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit results information one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. * Results returned after quality control review The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator. * Results submitted to ClinicalTrials.gov Indicates that the study sponsor or investigator has submitted summary results information for a clinical study to ClinicalTrials.gov but the quality control (QC) review process has not concluded. The results submitted date indicates when the study sponsor or investigator first submitted summary results information or submitted changes to summary results information. Submissions with changes are typically in response to QC review comments from the National Library of Medicine (NLM). If there is a date listed for results submitted to ClinicalTrials.gov, but there is not a subsequent date listed for results returned after quality control review, this means that the submission is pending review by NLM. * Secondary outcome measure In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure. * Serious adverse event An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. * Sex A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility. * Sham comparator arm An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components. * Single group assignment A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment. * Sort studies by In Advanced Search, the Sort studies by option is used to change the order of studies listed on the Search Results page. You can sort by Relevance or Newest First: * Relevance: Studies that best match your search terms appear higher in the search results list. This is the default display for all searches. * Newest First: Studies with the most recent First posted dates appear higher in the search results list. * Sponsor The organization or person who initiates the study and who has authority and control over the study. * State In the search feature, the State field is used to find clinical studies with locations in a specific state within the United States. If you choose United States in the Country field, you can search for studies with locations in a specific state. * Statistical analysis plan (SAP) The written description of the statistical considerations and methods for analyzing the data collected in the clinical study. * Status Indicates the current recruitment status or the expanded access status. * Study completion date The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date. * Study design The investigative methods and strategies used in the clinical study. * Study documents Refers to the type of documents that the study sponsor or principal investigator may add to their study record. These include a study protocol, statistical analysis plan, and informed consent form. * Study IDs Identifiers that are assigned to a clinical study by the study's sponsor, funders, or others. They include unique identifiers from other trial study registries and National Institutes of Health grant numbers. Note: ClinicalTrials.gov assigns a unique identification code to each clinical study registered on ClinicalTrials.gov. Also called the NCT number, the format is "NCT" followed by an 8-digit number (for example, NCT00000419). * Study record An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; contact information; and, in some cases, summary results. Each study record is assigned a ClinicalTrials.gov identifier, or NCT number. * Study registry A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies. * Study results A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events). * Study start date The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date. * Study type Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. * Submitted date The date on which the study sponsor or investigator submitted a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. * Title The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public. * Title acronym The acronym or initials used to identify a clinical study (not all studies have one). For example, the title acronym for the Women's Health Initiative is "WHI." * type of intervention A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. * U.S. Agency for Healthcare Research and Quality (AHRQ) An agency within the U.S. Department of Health and Human Services. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. * U.S. Food and Drug Administration (FDA) An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure. * Unknown A type of recruitment status. 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Completed CLINICAL TRIAL OF A MEDICAL DEVICE "DEVICE FOR NON-INVASIVE ELECTROMAGNETIC THERAPY "TOR" IN THE TREATMENT OF COVID-19" ClinicalTrials.gov ID NCT05220579 Sponsor Concern GRANIT Information provided by Concern GRANIT (Responsible Party) Last Update Posted 2022-02-02 Expand all content Collapse all content Study DetailsResearcher ViewNo Results PostedRecord History On this page Study Overview Contacts and Locations Participation Criteria Study Plan Collaborators and Investigators Publications Study Record Dates More Information STUDY OVERVIEW Brief Summary A clinical trial was conducted with human participation in order to assess the safety and efficacy of the medical device "TOR device for non-invasive electromagnetic therapy" when used as an adjunct in combination with standard COVID-19 treatment methods to accelerate the elimination (elimination) of the SARS-COV-2 virus from the nasopharynx in patients diagnosed with COVID-19. Device principle of operation is based on the use of weak electromagnetic radiation, continuously induced by high-voltage pulses on the launcher of a pulsed electromagnetic field electrodes and causing noise in the SARS-CoV-2 virus. The study included 236 patients who met all of the specified criteria: male and female patients aged ≥ 18 years with a coronavirus infection COVID-19 established diagnosis after specific testing, with a course of moderate disease, who do not require mechanical ventilation at the time of enrollment in the study. Infection with the SARS-CoV-2 virus had to be confirmed by PCR (nasopharyngeal and oropharyngeal swab). Informed consent was obtained from all patients. Results were statistically evaluated for 222 patients due to death and exclusion from the clinical study of 14 patients. Patients of the test group were exposed to the "TOR" device for at least 5 (five) consecutive days for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break) in combination with standard therapy. Patients in the placebo group were exposed to the switched off "TOR" device in combination with standard therapy. The control group received standard therapy. Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the current version of the Temporary guidelines of the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". The study had the periods of screening (day 1, visit 0 - V0), treatment (days 2-6, visits 1-5 - V1-V5), discharge (day 7-14, visit 6 - V6), follow-up (day 26 -30, visit 7 - V7). As a result of the clinical trial, it was established: "The device of non-invasive electromagnetic therapy "TOR" is safe when used as directed; effective as an adjuvant in combination with standard COVID-19 treatments to accelerate the elimination of the SARS-COV-2 virus from the nasopharynx. Show more Detailed Description This is a research work with the participation of patients to study the effect of low-power electromagnetic radiation with a selected spectrum on infected cells and the SARS-CoV-2 virus itself. In the course of work with wave emitters Research center of JSC "Concern GRANIT" conducted research in the field of the body's response to various wave frequencies and their combinations. In February 2020, the Concern's specialists, based on open information, created a computer model of the SARS-CoV-2 virus (COVID-19). After creating the simulation, work was carried out to isolate the spectrum of the wave emanating from the COVID-19 virus colony and infected cells. The resulting spectrum was modified for the purpose of noise pollution, and as a result the virus should lose activity and the standard line of behavior, which in turn should lead to a pause in its spread and enable the human immune system to cope with the infection on its own. Based on these assumptions, the prepared wave spectrum was recorded into the "TOR" device emitter, acting with an electromagnetic field with an intensity not exceeding that of a household microwave oven. The resulting spectrum is directed by the "TOR" device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity. Thus, investigators are talking about a method aimed to changing the SARS-CoV-2 virus behavior, both outside a healthy cell and inside an infected one. The main task of this method is to bring low-power electromagnetic radiation with a selected spectrum as close as possible to infected cells and the virus itself. The safety of the "TOR" device is confirmed by the Institute of the Federal State Budgetary Institution "ALL-RUSSIAN RESEARCH AND TESTING INSTITUTE OF MEDICAL TECHNOLOGY" of Roszdravnadzor (permission to conduct tests No. 876/2020 dated 10.12.2020 was issued by Roszdravnadzor). The clinical study was carried out by the Federal State-Funded Educational Institution "Samara State Medical University" of the Ministry of Health of the Russian Federation. Address: 443099 Samara region, Samara, st. Chapaevskaya, 89 The main objective of the study was: to assess the safety and efficacy of the medical device ""TOR" device for non-invasive electromagnetic therapy" when used as an adjunct in combination with standard COVID-19 treatment methods to accelerate the elimination (elimination) of the SARS-COV-2 virus from the nasopharynx in patients diagnosed with COVID-19. Primary performance parameters were: 1. Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR. 2. Dynamics of changes in the number of banded neutrophils. Secondary performance parameters were: 1. Dynamics of saturation, respiratory rate. 2. The dynamics of changes in points on the WHO scale; 3. Dynamics of changes in points on the NEWS scale; Within the framework of the study, three cohorts were formed, in each patients were randomized into control group A, receiving only standard therapy, group B with the exposure to the "TOR" device plus standard therapy, and group C with simulated exposure to the "TOR" device (placebo) in combined with standard therapy. Patients were randomly assigned to groups by randomization at visit 1 (day 1) in a 1: 1 ratio. Group A consisted of 84 people (during the study, 73 patients remained due to the death of 11 patients), group B - 77 people (during the study, 75 patients remained due to the death of 2 patients), group C - 75 people (during the study 74 patients remained due to the death of 1 patient). Before the start of treatment, there were no statistically significant differences in the main clinical and functional parameters between patients of all groups, with the exception of anthropometric data, which was taken into account during the study. Cohort 1, exposure to the "TOR" device: • Patients undergo standard therapy + exposure to the "TOR" device Modes of patients' treatment with the "TOR" device: The exposure is carried out for at least 5 (five) days in a row for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break). Longer exposure does not have a negative effect on the human body. Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Cohort 2, placebo: • Patients undergo standard therapy + a switched off "TOR" device was installed in the wards Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Cohort 3, control: • Patients received standard therapy Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". The study provides for the following periods: * Screening period / enrollment and initiation of symptomatic therapy - day 1, V0; * Treatment period - 2-6 days, V1-V5; * Discharge period - 7-14 days, V6; * Follow-up period: 26-30th day, V7. Thus, the maximum duration of participation in the study for one patient was 30 days. Visit 0 (screening / enrollment / initiation of symptomatic treatment): Day 1 During the visit, the following procedures were performed: * Signing an informed consent form for participation in the study; * Collection of demographic data (date of birth, gender, age); * Collecting anamnesis; * Documenting a positive result of a PCR swab from the nasopharynx and / or oropharynx for SARS-CoV-2 no more than 72 hours old on the day of screening; * Documenting the results of a previously performed CT scan of the lungs; * Registration of complaints; * Registration of concomitant therapy; * Assessment of basic vital signs (blood pressure, heart rate [HR], respiratory rate) daily during hospitalization; * Measurement of axillary body temperature once a day * Physical examination; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * Coagulogram (activated partial thromboplastin time [APTT], PT, fibrinogen); * General urine analysis (color, transparency, relative density, pH, glucose, protein, ketone bodies, urobilinogen); * Assessment of SpO2 daily during hospitalization; * Electrocardiogram (ECG): performed to assess the QT interval; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of inclusion / non-inclusion criteria; * Enrollment in the research; * Exposure of the method according to the Protocol; * Assessment of AEs / SAEs related to research procedures; * Assessment of exclusion criteria. Visits 1-5 (treatment period): days 2-6 During the visit, the following procedures were performed: * Exposure of the patient with the "TOR" device; * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate) daily during the period of hospitalization; * Daily measurement of axillary body temperature during hospitalization; * Assessment of SpO2 daily during hospitalization; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE; * Assessment of exclusion criteria. Visit 6 (end of treatment period, discharge): Day 7-14 During the visit, the following procedures were performed: * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate); * Measurement of axillary body temperature; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * SpO2 assessment; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE; * Assessment of exclusion criteria. Visit 7 (Follow-up): Day 26-30 During the visit, the following procedures were performed: * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate); * Measurement of axillary body temperature; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * SpO2 assessment; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE. Show more Official Title A Randomized Blind Placebo-controlled 3rd Phase Study of the Safety and Efficacy of the Device "Device for Non-invasive Electromagnetic Therapy "TOR" in 236 Patients Diagnosed With Moderate Coronavirus Infection Conditions Coronavirus Infection COVID-19 Intervention / Treatment * Device: Exposure to "TOR" device * Device: Exposure to switched off "TOR" device * Device: Exposure to "TOR" device * Device: Exposure to switched off "TOR" device Other Study ID Numbers * SamaraTOR1 Study Start (Actual) 2020-12-29 Primary Completion (Actual) 2021-08-12 Study Completion (Actual) 2021-08-12 Enrollment (Actual) 236 Study Type Interventional Phase Not Applicable RESOURCE LINKS PROVIDED BY THE NATIONAL LIBRARY OF MEDICINE MedlinePlus(https://medlineplus.gov/) related topics: COVID-19 (Coronavirus Disease 2019)(https://medlineplus.gov/covid19coronavirusdisease2019.html) FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links) CONTACTS AND LOCATIONS This section provides the contact details for those conducting the study, and information on where this study is being conducted. Russian Federation Moscow, Russian Federation, 119019 Concern GRANIT Click to view interactive map PARTICIPATION CRITERIA Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies). Eligibility Criteria Description Inclusion Criteria: 1. Men and women aged 18 and over, diagnosed with coronavirus infection COVID-19 after specific testing. When the course of the disease progressed to a severe degree, patients were excluded from the study; 2. Signed consent to participate in the trial; 3. Patients hospitalized with COVID-19 disease. Positive result of a PCR test (biomaterial - a swab from the nasopharynx and / or oropharynx) for infection with the SARS-CoV-2 virus within 72 hours on the day of screening. 4. Patients with characteristic computed tomographic signs of the "ground-glass opacity" (one or two-sided spread) in combination with local foci of consolidation or without them; 5. Oxygen therapy is not required, or oxygen therapy is required using a face mask or nasal cannulas; 6. The duration of the disease from the first symptoms to the day of screening is not more than 7 days; 7. The ability to understand the requirements for research participants, to give written consent to participate in the research (including the use and transfer of information about the health of patients, relevant to the research) and to follow the procedures specified in the research protocol. Exclusion Criteria: 1. The patient's desire to discontinue participation in the study (withdrawal of informed consent). 2. The decision of the investigating physician that the patient should be excluded for the benefit of the patient him/herself; 3. The patient refuses to cooperate with the investigator or is not disciplined; 4. Death of the patient; 5. Progressing of the disease to a severe degree. Show more Ages Eligible for Study 18 Years and older (Adult, Older Adult ) Sexes Eligible for Study All Accepts Healthy Volunteers No STUDY PLAN This section provides details of the study plan, including how the study is designed and what the study is measuring. Expand all / Collapse all How is the study designed? Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Randomized placebo controlled double-blind trial Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor) Masking Description: The "TOR" device was provided by the sponsor to the investigators with screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators. Arms and Interventions Participant Group/Arm Intervention/Treatment Participant Group/Arm Experimental: Exposure to "TOR" device Patients undergo standard therapy + exposure to the "TOR" device Modes of patients' treatment with the "TOR" device: The exposure is carried out for at least 5 (five) days in a row for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break). Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Intervention/Treatment Device: Exposure to "TOR" device * Specific wave spectrum is directed by the "TOR" device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity. Participant Group/Arm No Intervention: Control Patients received standard therapy Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Intervention/Treatment Participant Group/Arm Placebo Comparator: Placebo (exposure to switched off "TOR" device) Patients undergo standard therapy + a switched off "TOR" device was installed in the wards Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Intervention/Treatment Device: Exposure to switched off "TOR" device * The "TOR" device has screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators. What is the study measuring? Primary Outcome Measures Outcome Measure Measure Description Time Frame PCRDynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR.Day 5PCRDynamics of changes in the number of banded neutrophils.Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR.Day 14Banded neutrophilsDynamics of changes in the number of banded neutrophils.Day 7Banded neutrophilsDynamics of changes in the number of banded neutrophils.Day 14Banded neutrophilsDynamics of changes in the number of banded neutrophils.Day 28 Secondary Outcome Measures Outcome Measure Measure Description Time Frame Blood oxygen saturationDynamics of saturation.Day 2Blood oxygen saturationDynamics of saturation.Day 3Blood oxygen saturationDynamics of saturation.Day 4Blood oxygen saturationDynamics of saturation.Day 5Respiratory rateDynamics of respiratory rate.Day 2Respiratory rateDynamics of respiratory rate.Day 3Respiratory rateDynamics of respiratory rate.Day 4Respiratory rateDynamics of respiratory rate.Day 5Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 2Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 3Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 4Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 5Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 7Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 14Ordinal Scale for Clinical ImprovementThe dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome).Day 28NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 2NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 3NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 4NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 5NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 7NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 14NEWS-2 (National Early Warning Score) scaleDynamics of changes in points on the NEWS-2 scale (score 0 - >/= 7, 0 - best outcome, >/= 7 - worst outcome).Day 28 COLLABORATORS AND INVESTIGATORS This is where you will find people and organizations involved with this study. Sponsor Concern GRANIT Collaborators * Samara State Medical University Investigators * Principal Investigator:Oleg V Fatenkov, Ph.D, M.D.,Samara State Medical University PUBLICATIONS The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study. General Publications No publications available * Find Publications about Study Results and related Pubmed Publications in the “Results” section of the study record. STUDY RECORD DATES These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website. Study Registration Dates First Submitted 2022-01-19 First Submitted that Met QC Criteria 2022-02-01 First Posted 2022-02-02 Study Record Updates Last Update Submitted that met QC Criteria 2022-02-01 Last Update Posted 2022-02-02 Last Verified 2021-09 MORE INFORMATION Record History Expand all / Collapse all TERMS RELATED TO THIS STUDY Keywords Provided by Concern GRANIT Coronavirus Infection COVID-19 electromagnetic therapy SARS-CoV-2 Additional Relevant MeSH Terms Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Infections COVID-19 Coronavirus Infections PLAN FOR INDIVIDUAL PARTICIPANT DATA (IPD) Plan to Share Individual Participant Data (IPD)? Yes IPD Plan Description We provide the Clinical Study Protocol upon request to the administrator's email. IPD Sharing Access Criteria Upon request to the administrator's email address gryaznov.v@granit-concern.ru IPD Sharing Time Frame Until December 31, 2022 IPD Sharing Supporting Information Type Study Protocol DRUG AND DEVICE INFORMATION, STUDY DOCUMENTS, AND HELPFUL LINKS Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Study Documents No study documents available About About ClinicalTrials.gov Release Notes Site Map Help Give us feedback Glossary Customer Support Legal Disclaimer Terms and Conditions About * About ClinicalTrials.gov * Release Notes * Site Map Help * Give us feedback * Glossary * Customer Support Legal * Disclaimer * Terms and Conditions National Library of Medicine 8600 Rockville Pike, Bethesda, MD 20894 ClinicalTrials.gov An official website of the U.S. Department of Health and Human Services(https://www.hhs.gov), National Institutes of Health(https://www.nih.gov), National Library of Medicine(https://www.nlm.nih.gov), and National Center for Biotechnology Information(https://www.ncbi.nlm.nih.gov). * About HHS * About NIH * About NLM * About NCBI * Accessibility support * FOIA requests * No FEAR Act data * Office of the Inspector General * Privacy policy * HHS Vulnerability Disclosure Looking for U.S. government information and services? 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File Format CSV JSON FHIR JSON Data Fields Select fields (9): Select all / De-select all NCT Number Study Title Study URL Acronym Study Status Brief Summary Study Results Conditions Interventions Primary Outcome Measures Secondary Outcome Measures Other Outcome Measures Sponsor Collaborators Sex Age Phases Enrollment Funder Type Study Type Study Design Other IDs Start Date Primary Completion Date Completion Date First Posted Results First Posted Last Update Posted Locations Study Documents * Download * Cancel