Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC)

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2; Coronavirus Disease 2019 (COVID-19)
• Intervention / Treatment: Procedure: Biological sample collection; Procedure: Data Collection: Clinical Care Assessments

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.

• Study Type: Observational
• Enrollment (Actual): 1227

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
  • California
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles: Department of Medicine
    • San Francisco, California, United States, 94115
      • University of California San Francisco School of Medicine
    • Stanford, California, United States, 94305
      • Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health Gainesville
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville
    • Tampa, Florida, United States, 33606
      • University of South Florida Health Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30317
      • Emory University School Of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin: UT Health Austin
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine: Department of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Surveillance cohort; 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.

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.; 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.; Other Names: Baseline data, clinical care assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate Among COVID-19 Patients	The incidence of mortality in the first 28 days.	Day 1 to Day 28
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
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
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
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
Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28	Collected as part of clinical care.	Day 1 to Day 28
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28	A measure of disease morbidity.	Day 1 to Day 28
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
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
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
Mechanistic: Gene Expression (Transcriptomics) in Blood	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling	To identify and quantitate differences in immune response associated with disease outcome.	Up to 12 Months
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Boston Children's Hospital; Benaroya Research Institute
• Investigators: Study Chair: Nadine Rouphael, M.D., Emory University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): April 21, 2022

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: observational cohort surveillance study; immunologic assessments
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DAIT-COVID-19-002; NIAID CRMS ID#: 38733 (Other Identifier: DAIT NIAID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No