Official Title
A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
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.

Enrolling by invitation
Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2

Procedure: Biological sample collection
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.
Surveillance cohort

Procedure: Data Collection: Clinical Care Assessments
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.
Surveillance cohort
Other Name: Baseline data, clinical care assessments

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
Tucson, Arizona, 85724

University of California, Los Angeles: Department of Medicine
Los Angeles, California, 90024

University of California San Francisco School of Medicine
San Francisco, California, 94115

Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
Stanford, California, 94305

Yale School of Medicine
New Haven, Connecticut, 06520

University of Florida Health Gainesville
Gainesville, Florida, 32608

University of Florida Health Jacksonville
Jacksonville, Florida, 32209

University of South Florida Health Tampa
Tampa, Florida, 33606

Emory University School of Medicine
Atlanta, Georgia, 30317

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

University Hospitals Case Medical Center
Cleveland, Ohio, 44106

University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine
Oklahoma City, Oklahoma, 73126

Oregon Health & Science University
Portland, Oregon, 97239

Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102

University of Texas at Austin: UT Health Austin
Austin, Texas, 78712

Baylor College of Medicine: Department of Medicine
Houston, Texas, 77030

Nadine Rouphael, M.D.
Study Chair
Emory University

National Institute of Allergy and Infectious Diseases (NIAID)
Benaroya Research Institute
Boston Children's Hospital
NCT Number
Keywords
Covid-19
SARS-CoV-2
observational cohort surveillance study
immunologic assessments
MeSH Terms
Coronavirus Infections