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

NCT04582903 | Recruiting

• 2 other identifiers: 10000044000044-I
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infection

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Repository; Pandemic; Genetics; Proteomics; Natural History

Outcome Measures

Primary Outcomes (6)

• 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.

  End of Study

• 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.

  End of Study

• 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.

  End of Study

• 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.

  End of Study

• Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.

  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.

  End of Study

• Characterization of intrapatient SARS-CoV-2 genetic variation and evolution during infection and convalescence.

  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.

  End of Study

Study Arms (3)

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

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

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

Eligibility Criteria

• Age: 1 Day - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants enrolled onto this protocol must meet all of the following criteria:
• Aged 0-99 years (including viable neonates).
• Meets one of the following criteria:
• 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.
• For individuals considered for enrollment as uninfected individuals and biological relatives, able to provide informed consent.
• Willing to allow genetic testing.
• Willing to allow storage of samples and data for future research.

You may not qualify if:

• Individuals meeting any of the following criteria will be excluded from study participation:
• \. 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 infection with the emerging or re-emerging respiratory virus of interest despite negative testing for it.
• Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Niaid/Lcim

Rockville, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32405102 BACKGROUND

• 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.

  PMID: 32427334 BACKGROUND

• 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.

  PMID: 32292686 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helen C Su, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret A Abaandou

CONTACT

(301) 332-4870; margaret.abaandou@nih.gov

Helen C Su, M.D.

CONTACT

(301) 451-8783; hsu@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 12, 2020
• Study Start: October 13, 2020
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): January 31, 2031
• Last Updated: January 23, 2026

Record last verified: 2026-01-13

Locations

US (1)