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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373148
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, Stanford University

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.

Condition or disease Intervention/treatment
Coronavirus Other: There is no intervention

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19
Participants diagnosed with COVID-19
Other: There is no intervention
There is no intervention

Controls
Participants not diagnosed with COVID-19
Other: There is no intervention
There is no intervention




Primary Outcome Measures :
  1. Testing Immunity to SARS-CoV-2 over time [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Testing the virus over time [ Time Frame: 1 year ]

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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults (18 years and older) and children diagnosed and not diagnosed (controls) with COVID-19
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373148


Contacts
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Contact: SNP Center Inquiry (650) 521-7237 snpcenterallergy_inquiry@stanford.edu

Locations
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United States, California
Stanford Health Care - ValleyCare Not yet recruiting
Pleasanton, California, United States, 94588
Contact: Kathleen Jia, MD    832-533-1585    kjia@stanford.edu   
Stanford University, Hospital, and Clinics Recruiting
Stanford, California, United States, 94035
Contact: SNP Center Inquiry    650-521-7237    snpcenterallergy_inquiry@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kari Nadeau, MD, PhD Stanford University
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Responsible Party: Kari Christine Nadeau, MD PhD, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04373148    
Other Study ID Numbers: IRB-55689
2U19AI057229 ( U.S. NIH Grant/Contract )
20-006-ACTT ( Other Grant/Funding Number: Leidos Biomedical Research Inc. )
1U54CA260517-01 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kari Christine Nadeau, MD PhD, Stanford University:
Immunity
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases