Background:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease2019 (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 breathingproblems to life-threatening problems or death. Some people have no symptoms. This studyaims 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 thebody.Objective:To characterize the immune responses during and after SARS-CoV-2 infection and determineif 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 notinfected despite heavy exposure, and relatives of enrolled participants.Design:This is a sample collection protocol to receive send-in biological specimens forexploratory studies, including gene testing. Participants will not be seen at the NIH forstudy visits.Study staff will talk with participants health care providers to screen them for thestudy. Participants enrolled into the protocol will send samples and clinical informationat least once and more often if the participant has COVID-19. All participants willprovide blood samples and possibly stool. We may also ask for left over specimens fromany medical procedures completed as part of medical care. The study staff will alsorequest participants health care providers to complete a survey to collect demographicand medical data. Some of this information may need to be provided directly by theparticipant.Pregnant individuals are invited to participate and may be asked to give cord bloodsamples after delivery. Study findings that affect participants health may be shared withtheir health care provider. Depending on findings, participants may be contacted to takepart in other NIH studies.
In response to the public health emergency posed by the coronavirus disease 2019
(COVID-19) pandemic, researchers at the National Institute of Allergy and Infectious
Diseases (NIAID) are leading a large international collaboration to characterize the
innate and adaptive immune responses to acute severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection and convalescence. This protocol will allow the
NIAID Laboratory of Clinical Immunology and Microbiology (LCIM) to remotely enroll
participants for send-in sample collection for analyses to characterize the immune
response to SARS-CoV-2, better enabling the LCIM to support NIAID s commitment to
safeguarding the health of Americans and people around the world by accelerating research
efforts to characterize SARS CoV 2. This is a prospective sample collection protocol to
receive send in biological samples (e.g., blood, saliva, stool, and leftover clinically
collected samples) for exploratory studies to characterize the immune response to COVID
19. Participants will not be seen at the NIH for study visits. Under this protocol,
samples will be collected longitudinally from up to 300 patients with confirmed or
suspected SARS CoV 2 infection and sent to the NIH for research evaluations.
Additionally, samples will be collected from up to 200 uninfected patients and patient
relatives. Testing will be performed to improve understanding of host immune responses to
COVID-19, including but not limited to genetic, molecular, and proteomic testing.
Findings relevant to participants health and medical care may be returned to them and
their referring health care providers or study teams.
- INCLUSION CRITERIA:
Participants enrolled onto this protocol must meet all of the following criteria:
1. Aged 0-99 years (including viable neonates).
2. Meets one of the following criteria:
1. 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;
2. Individual who has remained uninfected with negative SARS-CoV-2 serologies
despite heavy or extensive COVID-19 exposure in the workplace or home
environment; or
3. Biological relative of a participant being studied under this protocol.
Relatives may be biological mother, father, siblings, children, grandparents,
aunts, uncles, or first cousins.
3. For individuals considered for enrollment as uninfected individuals and biological
relatives, able to provide informed consent.
4. Willing to allow genetic testing.
5. Willing to allow storage of samples and data for future research.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study
participation:
1. Any condition that, in the opinion of the investigator, contraindicates
participation in this study.
Since patients can be concurrently infected with multiple respiratory viruses, positive
testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an
individual from study participation where there remains a high clinical suspicion of
COVID-19 infection despite negative testing for SARS-CoV-2.
Co-enrollment guidelines: Participants may be co-enrolled in other studies; however,
study staff should be notified of co-enrollment.
Niaid/Lcim
Rockville, Maryland, United States
Investigator: Helen Su, M.D. Ph. D
Contact: 301-451-8783
hsu@niaid.nih.gov
Margaret A Abaandou
(301) 761-7627
margaret.abaandou@nih.gov
Helen C Su, M.D.
(301) 451-8783
hsu@mail.nih.gov
Helen C Su, M.D., Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)