- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373148
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
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
Additional Relevant MeSH Terms
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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