COVID-19NCT04371432
Genetics of COVID-19 Susceptibility and Manifestations
An observational study of COVID-19 and Coronavirus 2019, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Read more about this study
- Who is it for?
- Ages 1 month to 110 years
- Conditions the study is for
- COVID-19, Coronavirus 2019
- How many people
- 721 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This protocol will only enroll identifiable participants by invitation only. De-identified biospecimens and/or other clinical information may be analyzed. All prospective study participants will be notified of their potential eligibility by an established contact at the NIH Clinical Center. Cohort 1= Existing NIH Clinical Center inpatients/participants tested positive for SARS-CoV-2 invited to participate by their NIH study team; Cohort 2= Individuals recruited through NIH OMS, patients referred by collaborators, patients who self-refer, tested positive for SARS-CoV-2 with mild or severe manifestations of COVID-19 disease (and selected relatives of participants irrespective of infection status)
Who may be able to join
- Cohort 1 (Existing NIH Clinical Center Patient/Participants invited to participate by their NIH study team)
- Cohort 2 (Individuals recruited through NIH Occupational Medicine Services (OMS) patients referred by NIH investigators or other providers; individuals who self-refer)
- Located in the United States
- Positive test for SARS-CoV-2 virus infection
- Age greater than or equal to 3 years old
- only for participants providing a blood sample
Who cannot join
- Individuals for whom we cannot consent for participation in a language offered by our existing interpretation service.
- Weight less than 10 kg*
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others.
Read more
Objective:
This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people.
Eligibility:
Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff).
Design:
Participants will complete a questionnaire about their health history and COVID-19 symptoms.
Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA.
The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code.
Participants may be contacted by study team members for up to a year after they join the study.
Read the detailed description
The current SARS-CoV-2 pandemic presents a serious challenge to public health. Individuals infected with SARS-CoV-2 experience extremes in symptomatology ranging from a complete lack of symptoms to rapidly worsening end-stage pulmonary disease. The explanatory mechanism underlying susceptibility to severe disease remains unknown. We hypothesize that underlying genetic factors are at least partially explanatory. We aim to employ a phenotypic extremes approach to rapidly ascertain severely and mildly affected COVID-19 patients for genomic interrogation to identify germline and somatic variants that may play a role in host susceptibility to disease to correlate those phenotypic extremes with genetic variants. We will employ both a rare and common variant approach, using both genome sequencing and SNP chip analysis and B and T cell repertoire interrogation.
- Conditions
- COVID-19, Coronavirus 2019
- Keywords
- SARS-CoV-2, Whole Exome Sequencing, Coronavirus 2019, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sample Group 1 (NIHCC) | Existing NIH Clinical Center patients/participants tested positive for SARS-CoV-2 invited to participate by their NIH study team | |
| Sample Group 2 (OMS & Field) | Recruited through NIH OMS, referred by collaborators or who self-refer, tested positive for SARS-CoV-2 (and selected relatives of participants irrespective of infection status) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular etiology of host susceptibility to severe COVID-19
Identify common and rare germline variants associated with host susceptibility to severe or fatal COVID-19 disease using a case-case design.
Measured: Ongoing
Secondary outcomes (1)
Mechanisms of disease
Perform exploratory analyses of epigenetic signatures, serologic immune markers and antibody profiles, and other possible techniques to discover other mechanisms of disease.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start5 May 2020
- Primary completion23 Nov 2021
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leslie G Biesecker, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371432
- Sponsor's protocol ID
- 200090
- Other IDs
- 20-HG-0090
- Status last verified
- 19 Aug 2026
- First submitted
- 29 Apr 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be deposited into the database of genotypes and phenotypes (dbGaP), which is designed with tiered access to clinical data. There is open, public access to summary clinical data of study participants and qualified investigators may apply for access to individual, coded clinical results. Access is limited to authorized medical researchers and redistribution and security policies are strict. Broad future use of data deposited into dbGaP will be permitted.@@@De-identified data will be made available to collaborators. As members of the COVID-19 Host Genetics Initiative and we will collaborate and share data on rare variant analyses with the consortium, per NIH policy.@@@This study will comply with the NIH GDS Policy.@@@Samples and/or data may be shared with other researchers in coded form if their studies relate to the broadly defined purpose of increasing the understanding of the genetic contributions to disease expression of COVID-19, per NIH policy.@@@
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of COVID-19 Susceptibility and Manifestations
- ClinicalTrials.gov ID
- NCT04371432
- Acronym / sponsor ID
- 200090
- Conditions
- COVID-19, Coronavirus 2019
- Keywords
- SARS-CoV-2, Whole Exome Sequencing, Coronavirus 2019, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 5 May 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others.
Objective:
This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people.
Eligibility:
Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff).
Design:
Participants will complete a questionnaire about their health history and COVID-19 symptoms.
Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA.
The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code.
Participants may be contacted by study team members for up to a year after they join the study.
Detailed description
The current SARS-CoV-2 pandemic presents a serious challenge to public health. Individuals infected with SARS-CoV-2 experience extremes in symptomatology ranging from a complete lack of symptoms to rapidly worsening end-stage pulmonary disease. The explanatory mechanism underlying susceptibility to severe disease remains unknown. We hypothesize that underlying genetic factors are at least partially explanatory. We aim to employ a phenotypic extremes approach to rapidly ascertain severely and mildly affected COVID-19 patients for genomic interrogation to identify germline and somatic variants that may play a role in host susceptibility to disease to correlate those phenotypic extremes with genetic variants. We will employ both a rare and common variant approach, using both genome sequencing and SNP chip analysis and B and T cell repertoire interrogation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sample Group 1 (NIHCC) | – | –Existing NIH Clinical Center patients/participants tested positive for SARS-CoV-2 invited to participate by their NIH study team |
| Sample Group 2 (OMS & Field) | – | –Recruited through NIH OMS, referred by collaborators or who self-refer, tested positive for SARS-CoV-2 (and selected relatives of participants irrespective of infection status) |
Who may qualify
- Ages
- 1 month to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This protocol will only enroll identifiable participants by invitation only. De-identified biospecimens and/or other clinical information may be analyzed. All prospective study participants will be notified of their potential eligibility by an established contact at the NIH Clinical Center. Cohort 1= Existing NIH Clinical Center inpatients/participants tested positive for SARS-CoV-2 invited to participate by their NIH study team; Cohort 2= Individuals recruited through NIH OMS, patients referred by collaborators, patients who self-refer, tested positive for SARS-CoV-2 with mild or severe manifestations of COVID-19 disease (and selected relatives of participants irrespective of infection status)
Key inclusion criteria (6 listed)
- Cohort 1 (Existing NIH Clinical Center Patient/Participants invited to participate by their NIH study team)
- Cohort 2 (Individuals recruited through NIH Occupational Medicine Services (OMS) patients referred by NIH investigators or other providers; individuals who self-refer)
- Located in the United States
- Positive test for SARS-CoV-2 virus infection
- Age greater than or equal to 3 years old
Key exclusion criteria (2 listed)
- Individuals for whom we cannot consent for participation in a language offered by our existing interpretation service.
- Weight less than 10 kg*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular etiology of host susceptibility to severe COVID-19
Time frame: Ongoing
Identify common and rare germline variants associated with host susceptibility to severe or fatal COVID-19 disease using a case-case design.
1 secondary outcome
Mechanisms of disease
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data may be deposited into the database of genotypes and phenotypes (dbGaP), which is designed with tiered access to clinical data. There is open, public access to summary clinical data of study participants and qualified investigators may apply for access to individual, coded clinical results. Access is limited to authorized medical researchers and redistribution and security policies are strict. Broad future use of data deposited into dbGaP will be permitted.@@@De-identified data will be made available to collaborators. As members of the COVID-19 Host Genetics Initiative and we will collaborate and share data on rare variant analyses with the consortium, per NIH policy.@@@This study will comply with the NIH GDS Policy.@@@Samples and/or data may be shared with other researchers in coded form if their studies relate to the broadly defined purpose of increasing the understanding of the genetic contributions to disease expression of COVID-19, per NIH policy.@@@
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie G Biesecker, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus 2019, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular etiology of host susceptibility to severe COVID-19 (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.