Genetics of COVID-19 Susceptibility and Manifestations

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    2500
  • sponsor
    National Human Genome Research Institute (NHGRI)
Updated on 19 February 2024
organ failure
pneumonia
covid-19
SARS
acute respiratory syndrome (sars)

Summary

Background

The current SARS-CoV-2 pandemic presents a serious challenge to public health. Some people who are infected with SARS-CoV-2 have mild symptoms or none at all. But others develop severe symptoms, like pneumonia or organ failure. Researchers think that people s genes might play a role in how sick they get. Researchers want to look at the genes of people who have tested positive for COVID-19 to learn more.

Objective

To learn more about COVID-19 by studying the DNA of people who have tested positive for it, and to share data as fast as possible with other qualified researchers who are also trying to learn more about COVID-19.

Eligibility

People ages 3 years and older who have tested positive for COVID-19 and are being treated at the NIH Clinical Center or have tested positive through the Occupational Medical Service

Design

Participants will complete a questionnaire about their health history and COVID-19 symptoms.

Participants will give a blood sample. It will be about 2 tablespoons of blood. Researchers will use this blood 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 give their blood sample.

...

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.

Details
Condition Covid 19, Coronavirus 2019
Age 3-100 years
Clinical Study IdentifierNCT04371432
SponsorNational Human Genome Research Institute (NHGRI)
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

FOR Cohort 1 (Existing NIH Clinical Center Patient/Participants invited to participate by their NIH study team) and Cohort 2 (Individuals recruited through NIH Occupational Medicine Services (OMS) invited to participate by OMS)
Positive test for SARS-CoV-2 virus infection
Weight greater than or equal to 10 kg
Age greater than or equal to 3 years old

Exclusion Criteria

Individuals invited to participate for whom we cannot consent for participation in a language offered by our existing interpretation service
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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