Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence

Part of paid clinical trials in Rockville, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04582903
Status
Recruiting
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Conditions

  • COVID-19 Infection

Eligibility Criteria

Sex
ALL
Age
1 Day - 99 Years
Healthy Volunteers
Accepted

Study Details

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.

Key Dates

Start date
Oct 13, 2020
Status verified
Jan 2026
Primary completion
Aug 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: Biological Relative
    Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins
  • Arm: Confirmed or Suspected SARS-CoV-2 infection
    Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or current), typically but not always supported by a positive PCR test for viral RNA
  • Arm: Exposed but Uninfected
    Individual who has remained uninfected with negative SARS-CoV-2 serologies despite heavy or extensive COVID-19 exposure in the workplace or home environment

Primary Outcome Measure

Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence. [ Time Frame: End of Study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Niaid/LcimRockvilleMaryland20892
Helen Su, M.D. Ph. D
[email protected]
301-451-8783

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