Status:
COMPLETED
Immunophenotyping Assessment in a COVID-19 Cohort
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Benaroya Research Institute
Boston Children's Hospital
Conditions:
Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
Eligibility:
All Genders
18+ years
Brief Summary
This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secreti...
Detailed Description
This is a prospective observational cohort surveillance study of up to 2,000 adult participants hospitalized with known or presumptive COVID-19. Detailed information will be collected regarding patien...
Eligibility Criteria
Inclusion
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Participant and/or surrogate understands the data to be collected and the study procedures and is willing to participate in the surveillance cohort as described in the study information sheet;
- ≥ 18 years of age at the time of hospitalization; and
- Admitted to a hospital with presumptive or documented coronavirus disease 2019 (COVID-19), with confirmation of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection by Polymerase Chain Reaction (PCR).
Exclusion
- Individuals who meet any of these criteria are not eligible for enrollment as study participants:
- Underlying medical problems which, in the opinion of the investigator may be associated with mortality unrelated to COVID-19 within 48 hours of hospitalization, or a decision by the patient or surrogate prior to hospitalization to limit care to comfort measures; or
- Medical problems or conditions such as pregnancy which might impact interpretation of the immunologic data obtained.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
1227 Patients enrolled
Trial Details
Trial ID
NCT04378777
Start Date
May 1 2020
End Date
April 21 2022
Last Update
May 19 2022
Active Locations (17)
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1
University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
Tucson, Arizona, United States, 85724
2
University of California, Los Angeles: Department of Medicine
Los Angeles, California, United States, 90024
3
University of California San Francisco School of Medicine
San Francisco, California, United States, 94115
4
Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
Stanford, California, United States, 94305