Genetics of COVID-19 Susceptibility and Manifestations

Suspended

• Conditions: COVID-19; Coronavirus 2019

• Registration Number: NCT04371432
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

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.

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 Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-01
• Study Start: 2020-05-05
• Status Verified: 2024-08-23
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 721

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular etiology of host susceptibility to severe COVID-19	Ongoing	Identify common and rare germline variants associated with host susceptibility to severe or fatal COVID-19 disease using a case-case design.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States