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

June 13, 2022 updated by: Kari Christine Nadeau, MD, PhD, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Pleasanton, California, United States, 94588
        • Stanford Health Care - ValleyCare
      • Stanford, California, United States, 94305
        • Stanford University, Hospital, and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19
Participants diagnosed with COVID-19
There is no intervention
Controls
Participants not diagnosed with COVID-19
There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Testing Immunity to SARS-CoV-2 over time
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Testing the virus over time
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-55689
  • 2U19AI057229 (U.S. NIH Grant/Contract)
  • 1U54CA260517-01 (U.S. NIH Grant/Contract)
  • 1R21ES033049-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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