Genetics of COVID-19 Susceptibility and Manifestations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus 2019 Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 month–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA
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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Mechanisms of disease

Time frame: Ongoing

Perform exploratory analyses of epigenetic signatures, serologic immune markers and antibody profiles, and other possible techniques to discover other mechanisms of disease.

Sponsors and collaborators

Lead sponsor

National Human Genome Research Institute (NHGRI)

Nih

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2024
First posted: May 1, 2020
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed