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.
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 patient history and onset of illness upon enrollment. Participants will undergo longitudinal assessments of clinical status and pertinent clinical data (including clinical laboratory values, radiographic findings, medication use, oxygen and ventilatory support requirements, complications, etc.) will be recorded. In parallel, the study will conduct serial biologic sampling for detailed immunophenotyping to provide a comprehensive picture of immune changes that occur throughout the course of infection. The biologic samples to be collected for this observational study include blood, nasal swabs, and endotracheal aspirates. Participants will be followed in hospital through Day 28, unless discharged earlier. If a participant requires an escalation to Intensive Care Unit (ICU)-level care, either within or outside of a dedicated ICU, additional samples will be collected within 24 and 96 hours of care escalation. Convalescent questionnaires and biologic samples will be collected at 3-month intervals up to Month 12 after infection symptom onset, if available. In addition, if a participant is discharged from the hospital prior to Day 28, attempts will be made to collect additional scheduled assessments through Day 28 on an outpatient basis, if feasible.
Study Type
OBSERVATIONAL
Enrollment
1,227
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.
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
...and 7 more locations
Mortality Rate Among COVID-19 Patients
The incidence of mortality in the first 28 days.
Time frame: Day 1 to Day 28
Proportion of Patients with COVID-19 who Require Intensive Care Unit (ICU)-Level Care, Mechanical Ventilatory Support (MV), and/or Extracorporeal Membrane Oxygenation (ECMO) Over Time to Day 28
As a measure of disease acuity and severity.
Time frame: Day 1 to Day 28
Proportion of Patients with COVID-19 who Develop Shock, Secondary Organ Failure, or Secondary Infection Over Time to Day 28
As a measure of disease acuity and severity.
Time frame: Day 1 to Day 28
Mechanistic: Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 28
Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.
Time frame: Day 1 to Day 28
Mechanistic: Antibody Isotype/Subclass Classification and Functionality Over Time through Day 28 and at follow-up through month 12
Focus on the immune response to SARS-CoV-2, seroconversion and immunoglobulin and transitions. Antibody isotypes present in a patient specimen(s) provide information about the timing of initial exposure and may provide insight on the progression of the disease and prognosis.
Time frame: Up to 12 Months
Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28
Collected as part of clinical care.
Time frame: Day 1 to Day 28
Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28
Collected as part of clinical care.
Time frame: Day 1 to Day 28
Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28
A measure of disease morbidity.
Time frame: Day 1 to Day 28
Proportion of Patients with COVID-19 with Requirement for New (Or Increased from Baseline if on Home Oxygen) Supplemental Oxygen Over Time to Day 28
A measure of disease morbidity.
Time frame: Day 1 to Day 28
Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28
A measure of disease morbidity.
Time frame: Day 1 to Day 28
Mechanistic: Immune Cell Frequencies and Activation Status (CyTOF) in Blood and Endotracheal Aspirate over time Through Day 28 and In blood at Select Study Visits Through Month 12
Method of immune profiling and quantitating the response to COVID-19 over time.
Time frame: Up to 12 Months
Mechanistic: Gene Expression (Transcriptomics) in Blood
To identify and quantitate differences in immune response associated with disease outcome.
Time frame: Up to 12 Months
Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium
To identify and quantitate differences in immune response associated with disease outcome.
Time frame: Up to 12 Months
Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein
To identify and quantitate differences in immune response associated with disease outcome.
Time frame: Up to 12 Months
Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling
To identify and quantitate differences in immune response associated with disease outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 12 Months
Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology
Circulating immune biomarkers will be explored by use of the OLINK® (name of brand), a multiplex protein biomarker discovery panel.
Time frame: Up to 12 Months