A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 1227
- Locations
- 17
- Primary Endpoint
- Mortality Rate Among COVID-19 Patients
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Mortality Rate Among COVID-19 Patients
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 to Day 28
Collected as part of clinical care.
Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28
Time Frame: Day 1 to Day 28
Collected as part of clinical care.
Secondary Outcomes
- 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)
- Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28(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(Up to 12 Months)
- Mechanistic: Gene Expression (Transcriptomics) in Blood(Up to 12 Months)
- Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28(Day 1 to Day 28)
- Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology(Up to 12 Months)
- Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium(Up to 12 Months)
- Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling(Up to 12 Months)
- Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein(Up to 12 Months)