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

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.

Visit ClinicalTrials.gov for details.