Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19

NCT04373148 | Completed

• 4 other identifiers: IRB-556892U19AI0572291U54CA260517-011R21ES033049-01
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test over time immunity to SARS-CoV-2, a recently identified coronavirus responsible for the 2019 world-wide pneumonia outbreak known as COVID-19. Adults and children diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Conditions

Coronavirus

Keywords

Immunity

Outcome Measures

Primary Outcomes (1)

• Testing Immunity to SARS-CoV-2 over time

  1 year

Secondary Outcomes (1)

• Testing the virus over time

  1 year

Study Arms (2)

COVID-19

Participants diagnosed with COVID-19

Other: There is no intervention

Controls

Participants not diagnosed with COVID-19

Other: There is no intervention

Interventions

There is no intervention OTHER

There is no intervention

COVID-19; Controls

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years and older) and children diagnosed and not diagnosed (controls) with COVID-19

You may qualify if:

• Adults (18 years and older) and children with confirmed COVID-19 (RT-PCR diagnosis).
• Adults (18 years and older) and children without COVID-19 for controls (who test negative for COVID-19 but may have viral symptoms)

You may not qualify if:

• Patients with special risks attendant to venipuncture will be excluded.

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Cancer Institute (NCI): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (2)

Stanford Health Care - ValleyCare

Pleasanton, California, 94588, United States

Location

Stanford University, Hospital, and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• Jia X, Cao S, Lee AS, Manohar M, Sindher SB, Ahuja N, Artandi M, Blish CA, Blomkalns AL, Chang I, Collins WJ, Desai M, Din HN, Do E, Fernandes A, Geng LN, Rosenberg-Hasson Y, Mahoney MR, Glascock AL, Chan LY, Fong SY; CLIAHUB Consortium; Chan Zuckerberg Biohub; Phelps M, Raeber O; Stanford COVID-19 Biobank Study Group; Purington N, Roltgen K, Rogers AJ, Snow T, Wang TT, Solis D, Vaughan L, Verghese M, Maecker H, Wittman R, Puri R, Kistler A, Yang S, Boyd SD, Pinsky BA, Chinthrajah S, Nadeau KC. Anti-nucleocapsid antibody levels and pulmonary comorbid conditions are linked to post-COVID-19 syndrome. JCI Insight. 2022 Jul 8;7(13):e156713. doi: 10.1172/jci.insight.156713.

  PMID: 35801588 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and optional nasopharyngeal swab, cheek swab with saliva collection, nasal swab, stool sample, blood microsample, and endotracheal aspirate (sputum samples)

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Kari Nadeau, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: April 8, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)