Immunophenotyping Assessment in a COVID-19 Cohort
- Conditions
- Coronavirus Disease 2019 (COVID-19)SARS-CoV-2
- Interventions
- Procedure: Biological sample collection
- Registration Number
- NCT04378777
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1227
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).
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surveillance cohort Biological sample collection Cohort descriptive data will include demographic variables (e.g. age, sex, race, ethnicity), clinical information on enrollment and key aspects of medical history (e.g. concomitant medications, for example). Patients will be longitudinally followed, up to 12 months.
- Primary Outcome Measures
Name Time Method Mortality Rate Among COVID-19 Patients Day 1 to Day 28 The incidence of mortality in the first 28 days.
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 Day 1 to Day 28 As a measure of disease acuity and severity.
Mechanistic: Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 28 Day 1 to Day 28 Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.
Proportion of Patients with COVID-19 who Develop Shock, Secondary Organ Failure, or Secondary Infection Over Time to Day 28 Day 1 to Day 28 As a measure of disease acuity and severity.
Mechanistic: Antibody Isotype/Subclass Classification and Functionality Over Time through Day 28 and at follow-up through month 12 Up to 12 Months 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.
Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28 Day 1 to Day 28 Collected as part of clinical care.
Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28 Day 1 to Day 28 Collected as part of clinical care.
- Secondary Outcome Measures
Name Time Method 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 Day 1 to Day 28 A measure of disease morbidity.
Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28 Day 1 to Day 28 A measure of disease morbidity.
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 Up to 12 Months Method of immune profiling and quantitating the response to COVID-19 over time.
Mechanistic: Gene Expression (Transcriptomics) in Blood Up to 12 Months To identify and quantitate differences in immune response associated with disease outcome.
Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28 Day 1 to Day 28 A measure of disease morbidity.
Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology Up to 12 Months Circulating immune biomarkers will be explored by use of the OLINK® (name of brand), a multiplex protein biomarker discovery panel.
Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium Up to 12 Months To identify and quantitate differences in immune response associated with disease outcome.
Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling Up to 12 Months To identify and quantitate differences in immune response associated with disease outcome.
Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein Up to 12 Months To identify and quantitate differences in immune response associated with disease outcome.
Trial Locations
- Locations (17)
University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
🇺🇸Tucson, Arizona, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
🇺🇸Stanford, California, United States
University of South Florida Health Tampa
🇺🇸Tampa, Florida, United States
University of Florida Health Gainesville
🇺🇸Gainesville, Florida, United States
University of Florida Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Texas at Austin: UT Health Austin
🇺🇸Austin, Texas, 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
University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine: Department of Medicine
🇺🇸Houston, Texas, United States