Immunophenotyping Assessment in a COVID-19 Cohort

SARS-CoV-2 Clinical Trial

— IMPACC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378777
• Other study ID #: DAIT-COVID-19-002
• Secondary ID: NIAID CRMS ID#:
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: April 21, 2022

Study information

• Verified date: May 2022
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1227
• Est. completion date: April 21, 2022
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• COVID-19
• SARS-CoV-2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Texas at Austin: UT Health Austin	Austin	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	University of Florida Health Gainesville	Gainesville	Florida
United States	Baylor College of Medicine: Department of Medicine	Houston	Texas
United States	University of Florida Health Jacksonville	Jacksonville	Florida
United States	University of California, Los Angeles: Department of Medicine	Los Angeles	California
United States	Yale School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine	Oklahoma City	Oklahoma
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
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	University of South Florida Health Tampa	Tampa	Florida
United States	University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Benaroya Research Institute, Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate Among COVID-19 Patients	The incidence of mortality in the first 28 days.	Day 1 to Day 28
Primary	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.	Day 1 to Day 28
Primary	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.	Day 1 to Day 28
Primary	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.	Day 1 to Day 28
Primary	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.	Up to 12 Months
Primary	Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28	Collected as part of clinical care.	Day 1 to Day 28
Primary	Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28	Collected as part of clinical care.	Day 1 to Day 28
Secondary	Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28	A measure of disease morbidity.	Day 1 to Day 28
Secondary	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.	Day 1 to Day 28
Secondary	Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28	A measure of disease morbidity.	Day 1 to Day 28
Secondary	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.	Up to 12 Months
Secondary	Mechanistic: Gene Expression (Transcriptomics) in Blood	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Secondary	Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Secondary	Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Secondary	Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Secondary	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.	Up to 12 Months

External Links

•   Division of Allergy, Immunology, and Transplantation
•   National Institute of Allergy and Infectious Diseases