Clinical trial NCT04378777: Immunophenotyping Assessment in a COVID-19 Cohort
Official title: A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
Keywords: observational cohort surveillance study
immunologic assessments
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Benaroya Research Institute
name: Boston Children's Hospital
First posted: 2020-05-07
Enrollment: 1227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult participants hospitalized with known or presumptive coronavirus disease 2019 (COVID-19), a human disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection.

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.

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.

Primary outcomes:
measure: Mortality Rate Among COVID-19 Patients
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: Day 1 to Day 28
measure: Proportion of Patients with COVID-19 who Develop Shock, Secondary Organ Failure, or Secondary Infection Over Time to Day 28
timeFrame: Day 1 to Day 28
measure: Mechanistic: Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 28
timeFrame: Day 1 to Day 28
measure: Mechanistic: Antibody Isotype/Subclass Classification and Functionality Over Time through Day 28 and at follow-up through month 12
timeFrame: Up to 12 Months
measure: Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28
timeFrame: Day 1 to Day 28
measure: Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: Day 1 to Day 28
measure: Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: Up to 12 Months
measure: Mechanistic: Gene Expression (Transcriptomics) in Blood
timeFrame: Up to 12 Months
measure: Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium
timeFrame: Up to 12 Months
measure: Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein
timeFrame: Up to 12 Months
measure: Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling
timeFrame: Up to 12 Months
measure: Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles: Department of Medicine
state: California
city: San Francisco
country: United States
facility: University of California San Francisco School of Medicine
state: California
city: Stanford
country: United States
facility: Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health Gainesville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Austin
country: United States
facility: University of Texas at Austin: UT Health Austin
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine: Department of Medicine
state: Texas
Study officials:
affiliation: Emory University
name: Nadine Rouphael, M.D.
role: STUDY_CHAIR
References: