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GLOSSARY

Study record managers: refer to the Data Element Definitions if submitting
registration or results information.

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 * 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
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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
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