Genetics of COVID-19 Susceptibility and Manifestations

COVID-19 Clinical Trial

Official title:

Genetics of COVID-19 Susceptibility and Manifestations

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04371432
• Other study ID #: 200090
• Secondary ID: 20-HG-0090
• Status: Suspended
• Start date: May 5, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: June 1, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 721
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

• 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*

Related Conditions & MeSH terms

• Coronavirus 2019
• Coronavirus Infections
• COVID-19

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page