Immunophenotyping Assessment in a COVID-19 Cohort

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Trial ID: NCT04378777

Purpose

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.

Official Title

A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)

Eligibility


Inclusion Criteria:

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 Criteria:

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.

Intervention(s):

procedure: Biological sample collection

procedure: Data Collection: Clinical Care Assessments

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hena Din, MPH
650-724-7253