Study record managers: refer to the Data Element Definitions if submitting registration or results information.
x
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
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.
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+)
A measure of all deaths, due to any cause, that occur during a clinical study.
A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
Another name for an interventional study.
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).
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.
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.
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.
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.
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.
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.
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).
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.
The
number of participants in a clinical study. The "estimated" enrollment
is the target number of participants that the researchers need for the
study.
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
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.
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.
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.
An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
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.
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.
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.
The date on which the study record
was first available on ClinicalTrials.gov. 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.
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).
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.
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.
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)
A type of eligibility criteria
that indicates whether eligibility to participate in a clinical study
is based a person's self-representation of gender identity or gender
(yes, no). Gender is distinct from sex.
A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.
A
process used by researchers to communicate to potential and enrolled
participants the risks and potential benefits of participating in a
clinical study.
The document used in the informed consent or process.
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.
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.
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.
A
researcher involved in a clinical study. Related terms include site
principal investigator, site sub-investigator, study chair, study
director, and study principal investigator.
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.
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).
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.
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.
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.
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.
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.
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.
An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Describes trials without FDA-defined phases, including trials of devices or behavioral interventions.
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.
An arm type in which a group of participants receives a placebo during a clinical trial.
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.
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.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
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.
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.
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
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.
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.
Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator.
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.
The
person responsible for submitting information about a clinical study to
ClinicalTrials.gov and updating that information. Usually the study
sponsor or investigator.
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.
Indicates that the sponsor or investigator submitted a certification or extension request.
The
date on which summary results information was first available on
ClinicalTrials.gov. 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.
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).
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.
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.
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.
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.
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.
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.
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.
A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
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.
The organization or person who initiates the study and who has authority and control over the study.
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.
The written description of the statistical considerations and methods for analyzing the data collected in the clinical study.
Indicates the current recruitment status or the expanded access status.
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.
The investigative methods and strategies used in the clinical study.
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.
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).
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.
A
structured online system, such as ClinicalTrials.gov, that provides the
public with access to summary information about ongoing and completed
clinical studies.
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).
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.
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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.
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.
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."
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
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A type of recruitment status.
It identifies a study on ClinicalTrials.gov whose last known status was
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the past 2 years. Studies with an unknown status are considered closed
studies.
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection
The safety and scientific validity of this study is the
responsibility of the study sponsor and investigators. Listing a study
does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
On
31 December 2019, the World Health Organization (WHO) was formally
notified about a cluster of cases of pneumonia in Wuhan City, China. On 7
January the responsible virus was isolated and its genome sequence was
shared on 12 January. It was named as COVID-19, a novel Coronavirus,
SARS-CoV-2. It is a member of the Corona virus family which is RNA
enveloped viruses.
Very rapidly the virus
emerged as pandemic. Now it is dominating the lives of every people of
this universe. Management of the COVID-19 relies on mainly supportive
care and oxygen supplementation via non-invasive or mechanical
ventilation in critical cases. Patients who are critically ill may also
require vasopressor support and antibiotics for secondary bacterial
infections.
There is no vaccine or
highly effective antiviral drugs for COVID-19. Currently there is a
tremendous effort around the world to develop effective preventive and
therapeutic treatment for this disease.
World Health
Organization has launched a non-blinded clinical trial (SOLIDARITY) to
evaluate four candidate treatments (remdesivir, lopinavir/ritonavir,
lopinavir/ritonavir/ interferon beta-1a, and chloroquine or
hydroxychloroquine) versus standard of care in 18 countries worldwide.
RECOVERY trial one of the largest trials to see the efficacy and safety
of hydroxychloroquine revealed that they are no clear cut clinical
benefit for COVID-19. Other drugs in the SOLIDARTY trial are quite
expansive for resource limited countries like Bangladesh.
Study Published in the
American Journal of Tropical Medicine advocates further research into
Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was
brought by Australian researchers from Monash University who
demonstrated its efficacy against the SARS-CoV-2 coronavirus in vitro
studies.
In different study
Doxycycline also showed promising results in treatment of COVID 19
infection. It is highly lipophilic antibiotics that are known to chelate
zinc component of matrix metalloprotienases (MMP). Corona viruses are
known to rely heavily of MMPs for survival, cell infiltration and
replication. It also has an anti-inflammatory effect which might be
effective in combating cytokine storm of Covid-19 infection.
So it have been planned
to conduct an experimental clinical trial using combination of
ivermectin and doxycycline for treatment of COVID 19 along with the
other standard care.
Condition or disease
Intervention/treatment
Phase
Covid19
Drug: Ivermectin and DoxycyclineDrug: Standard of care
Phase 3
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Detailed Description:
OBJECTIVES:
General objectives:
To observe the benefit (clinical and microbiological) of Ivermectin and Doxycycline in Confirmed Covid 19 cases.
Specific objectives:
To observe the clinical outcome in trial group and the placebo group.
To observe the duration require controlling viral replication (negative RT-PCR) in the trial and placebo group.
To compare the outcome between the two groups.
RATIONALE:
Covid-19 is an emergent
pandemic, threatens the life of millions of the people throughout the
globe. There is increasing effort of the scientist to unveil a remedy of
covid-19. Still it is unsuccessful. At present there is no other
alternative other than experimenting the existent drug against the
virus. There are several trials going throughout the globe. Among them
Ivermectin showed good efficacy in vitro trial. Some clinical trial also
proved it beneficial. The Doxycycline also has some anti viral role
with its prominent anti-inflammatory role. Synergistic action of the two
drugs might be proved some benefit in clinical trial. As both drugs are
cheap and less toxic, if it does, it would be the blessing for the poor
people of the globe.
METHODOLOGY:
Study type: Interventional Clinical trial Estimated enrollment: 200 participants per group
For superior trial, the formula is:
N=size per group; p=the
response rate of standard treatment group; p0= the response rate of new
drug treatment group; zx= the standard normal deviate for a one or two
sided x; d= the real difference between two treatment effect; δ0= a
clinically acceptable margin; S2= Polled standard deviation of both
comparison groups.
All parameters were assumed as follows: p =0.40; p0=0.58; α=0.05;β=0.20; δ=0.18; δ0=0.10.
However, we are assuming
that lost to follow up or refuse to include in trial will be 20%, that
means 24. So at least 150 patients will be allocated randomly and power
of this study will be 80%.
Allocation: Randomized
Intervention model: Parallel assignment Intervention model description:
Patient will be randomized 1:1 to placaebo with standard care and
combined doxycycline and ivermectin with standard care.
Blinding: Double blind
(The participant and the clinicians/data collectors will be unaware of
the treatment the participant receives) Primary purpose: Treatment
Official title: A phase III trial to promote recovery from covid 19 with
combined Doxycycline and Ivermectin along standard care. Provider of
placebo and active ingredients: Popular pharmaceutical limited Dosage of
the drugs: Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5
days
Data collection technique:
Data will be collected
by assigned. trained data collectors (Physician). Patient will be
enrolled according to defined inclusion and exclusion criteria in the
current research. Informed written consent will be obtained from the
patient or their relatives. Each patient participating in the trial will
be uniquely identified, and information such as his name, address is
recorded in the trial 'subject number list'. Only the principle
investigator will be aware about the allocation of the drugs. The
patients and the data collectors will be unaware about the group
allocation of the drugs. The Data will be reviewed by the
co-investigators. It will be managed by principle and co-principle
investigators in designated computer.
Clinical assessment
(fever, cough, Anorexia, Temperature, pulse, blood pressure, respiratory
rate, oxygen saturation) will be done every day. Routine investigation
(CBC, ESR, CRP, Creatinine, RBS, SGPT, chest x-ray, D- Dimer) will be
done at admission and at day 3, 5, 7, 10 and 14 day. In case of the
clinical deterioration it would done according to necessity. RT-PCR will
be done at day-0, Day 5, day 7 and day 14.
Standard care: both the experimental and placebo will receive the available standard of care, like-
Low molecular weight heparin according to indication
Appropriate other broad spectrum antibiotics
Other drugs for associated co- morbid condition
Management of the adverse events:
Drugs adverse effect
will be monitored by a defined committee. The patient experiencing
adverse effect of the drugs will be discontinued from the study. It will
be managed with priority to the highest possible level by the hospital
authority as well as the investigators.
If the patient
progresses from mild to moderate or severe disease, the study will be
continued and available management of the appropriate severity will be
immediately started. The patient will be monitored closely.
Data analysis:
Data will be analyzed by
computer with the help of SPSS (Statistical Package for Social
Sciences) version 26. Unpaired t-test would be used for testing
quantitative data and for testing qualitative data two sample z- test
will be used. Comparing drug outcome in between two groups hazard ratio,
Kaplan-Meire curve will be used.
Dropout management:
Likelihood based methods such as mixed models will be used to estimate
unbiased treatment effects, under assumptions regarding the missingness
mechanisms.
Patient will be randomized 1:1 to placaebo with standard care and combined doxycycline and ivermectin with standard care.
Masking:
Double (Participant, Investigator)
Masking Description:
Double blind (The participant and the clinicians/data collectors will be
unaware of the treatment the participant receives).The drugs will be
labelled with a random code number
Primary Purpose:
Treatment
Official Title:
A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care
Actual Study Start Date :
June 1, 2020
Actual Primary Completion Date :
August 22, 2020
Actual Study Completion Date :
September 10, 2020
Resource links provided by the National Library of Medicine
Number of Patients With Early Clinical Improvement [ Time Frame: 7 days ]
Number of patients have clinical improvement as described by WHO and Bangladesh local guideline with 7 days..
Body temperature remains normal for at least 3 days (ear temperature is lower than 37.5 °C).
Respiratory symptoms are significantly improved.
Lung imaging shows obvious improvement in lesions.
There is no co-morbidities or complications which require hospitalization.
SpO2, >93% without assisted oxygen inhalation.
Number of Participants With Late Clinical Recovery [ Time Frame: 12 days ]
Number of the patients required more than 12 days for clinical improvement as defined above.
Secondary Outcome Measures :
Number of Patients Having Clinical Deterioration. [ Time Frame: 1 month ]
Number
of patients deteriorating to next level of severity, like moderate,
severe and death. That is from mild illness at presentation with
subsequent follow up developed moderate, severe illness or death. Like
wise from moderate illness at presentation developed severe illness or
death.
Mild illness: These
patients usually present with symptoms of an upper respiratory tract
viral infection, including mild fever, cough (dry), sore throat, nasal
congestion, malaise, headache, muscle pain, or malaise. Signs and
symptoms of a more serious disease, such as dyspnea, are not present
Moderate illness: Respiratory symptoms such as cough and shortness of
breath (or tachypnea in children) are present without signs of severe
pneumonia.
Severe illness:severe dyspnea, respiratory distress, tachypnea (> 30 breaths/min), and hypoxia (SpO2 < 90% on room air).
Number of Patients Remain Persistently Positive for RT-PCR of Covid-19 [ Time Frame: 14 days ]
Number of Patients remain positive for RT-PCR of Covid-19 at day 14 after the day of initial positivity.
Choosing to participate in a study is an important personal
decision. Talk with your doctor and family members or friends about
deciding to join a study. To learn more about this study, you or your
doctor may contact the study research staff using the contacts provided
below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
COVID-19 infection, confirmed by polymerase chain reaction (PCR) test within 3 days from enrollment
Only mild and moderate COVID-19 infected cases
Able to provide informed consent
Exclusion Criteria:
Unable to take oral medication
Pregnant or breast feeding lady
Patients with severe COVID symptoms or admission in ICU/HDU
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper limit of normal (ULN)
On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
Known hypersensitivity to Doxycycline or ivermectin or its components.
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