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.
Aged 0-99 years (including viable neonates).
Patient with a known or suspected diagnosis of infection (past or current) with SARS-CoV-2 or an emerging or re-emerging respiratory virus, typically but not always supported by a positive PCR test for viral RNA;
Individual who has remained uninfected with negative virus serologies despite heavy or extensive exposure to the emerging or re-emerging respiratory virus in the workplace or home environment; or
Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins.
None
We plan to enroll up to 500 total participants in this protocol, including up to 300 patients with SARS-CoV-2 infection and 200 other participants (patient relatives and individuals who remain uninfected despite heavy or extensive COVID-19 exposure in the workplace or home environment). Health care providers worldwide will contact the study staff to request enrollment of patients and/or their relatives. Additionally, investigators may refer patients from other clinical studies.
Cohort
Prospective
Not listed
Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence.
These endpoints were chosen to provide in depth molecularmeasurements of a wide variety of innate and adaptive host immuneresponses to a novel pathogen in heterogenous patients. This is anexploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Survey of other potential blood proteomic biomarkers of disease.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
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