Genetics of COVID-19 Susceptibility and Manifestations

NCT04371432 | Completed

• 2 other identifiers: 20009020-HG-0090
• Study Type: observational
• Target: 721
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19; Coronavirus 2019

Keywords

SARS-CoV-2; Whole Exome Sequencing; Coronavirus 2019; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  Ongoing

Secondary Outcomes (1)

• Mechanisms of disease

  Ongoing

Study Arms (2)

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)

Eligibility Criteria

• Age: 1 Month - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• Individuals for whom we cannot consent for participation in a language offered by our existing interpretation service.
• Weight less than 10 kg\*

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Leslie G Biesecker, M.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 5, 2020
• Primary Completion: November 23, 2021
• Study Completion: December 15, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04-29

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared per NIH policy and available through the closure of the study. At the time the study is closed, a proposal to the IRB will be made to keep the data or destroy it.
• Access Criteria: dbGap is a controlled-access database with view-only access to summary-level information and individual-level genotype and sequence data associated with phenotypic features. @@@De-identified data from this study will be made available to collaborators and as members of the COVID-19 Host Genetics Initiative and we will extensively collaborate and share data on rare variant analyses with the consortium, per NIH policies on Genomic Data Sharing.@@@This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.@@@

Locations

US (1)