Clinical trial NCT04371432: Genetics of COVID-19 Susceptibility and Manifestations
Official title: Genetics of COVID-19 Susceptibility and Manifestations
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: COVID-19
Coronavirus 2019
Keywords: SARS-CoV-2
Whole Exome Sequencing
Coronavirus 2019
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-05-01
Enrollment: 721
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: * 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\*

Primary outcomes:
measure: Molecular etiology of host susceptibility to severe COVID-19
timeFrame: Ongoing
Secondary outcomes:
measure: Mechanisms of disease
timeFrame: Ongoing
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Human Genome Research Institute (NHGRI)
name: Leslie G Biesecker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: