Immunophenotyping Assessment in a COVID-19 Cohort
Completed
Conditions studied: Coronavirus Disease 2019 (COVID-19), SARS-CoV-2
In brief
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 secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.
Key facts
- Study ID
- NCT04378777
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 1227
- Starts
- 2020-05-01
- Expected to finish
- 2022-04-21
- Last updated by the study team
- 2022-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center — Tucson, Arizona, United States
- University of California, Los Angeles: Department of Medicine — Los Angeles, California, United States
- University of California San Francisco School of Medicine — San Francisco, California, United States
- Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research — Stanford, California, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- University of Florida Health Gainesville — Gainesville, Florida, United States
- University of Florida Health Jacksonville — Jacksonville, Florida, United States
- University of South Florida Health Tampa — Tampa, Florida, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
- University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine — Oklahoma City, Oklahoma, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
- University of Texas at Austin: UT Health Austin — Austin, Texas, United States
- Baylor College of Medicine: Department of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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