Clinical trial NCT04582903: Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Official title: Send-in Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Infection
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Repository
Pandemic
Genetics
Proteomics
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence.
timeFrame: End of Study
measure: Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.
timeFrame: End of Study
measure: Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.
timeFrame: End of Study
measure: Survey of other potential blood proteomic biomarkers of disease.
timeFrame: End of Study
measure: Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.
timeFrame: End of Study
measure: Characterization of intrapatient SARS-CoV-2 genetic variation and evolution during infection and convalescence.
timeFrame: End of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Niaid/Lcim
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Helen C Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casanova JL, Su HC; COVID Human Genetic Effort. A Global Effort to Define the Human Genetics of Protective Immunity to SARS-CoV-2 Infection. Cell. 2020 Jun 11;181(6):1194-1199. doi: 10.1016/j.cell.2020.05.016. Epub 2020 May 13.
citation: Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, Strich JR, Chertow DS, Davey RT, Cohen JI. Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Jun 29;222(2):206-213. doi: 10.1093/infdis/jiaa273.
citation: Gabutti G, d'Anchera E, Sandri F, Savio M, Stefanati A. Coronavirus: Update Related to the Current Outbreak of COVID-19. Infect Dis Ther. 2020 Jun;9(2):241-253. doi: 10.1007/s40121-020-00295-5. Epub 2020 Apr 8.