At a glance
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A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
In Brief
An observational study evaluating Biological sample collection and Data Collection: Clinical Care Assessments for Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2. Completed, enrolled 1,227 participants across 17 sites.
Detailed 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 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.
Study Details
Timeline
Interventions
During patient hospitalization: Nasal secretion samples by nasal swabs (for non-intubated patients), whole blood (blood draw/phlebotomy) and sputum secretions by endotracheal aspiration (for intubated patients) will be obtained to proceed with immunologic analysis of samples. DNA will be collected from whole blood at enrollment for genetic analysis (e.g., genome-wide association study \[GWAS\]). After hospital discharge: Collection of biologic samples (involving nasal swabs and blood draw/phlebotomy) will occur up to 12 months.
Baseline data and assessments obtained as part of ongoing clinical care will be collected throughout hospitalization for COVID-19. After hospital discharge, clinical status and activity assessments will occur up to 12 months.