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History of Changes for Study: NCT04378777
Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) (IMPACC)
Latest version (submitted May 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 6, 2020 None (earliest Version on record)
2 May 11, 2020 Contacts/Locations, Study Status and Study Identification
3 May 13, 2020 Recruitment Status, Study Status and Contacts/Locations
4 July 12, 2020 Study Status and Contacts/Locations
5 August 17, 2020 Study Status and Contacts/Locations
6 August 21, 2020 Contacts/Locations and Study Status
7 September 11, 2020 Study Status and Contacts/Locations
8 October 15, 2020 Contacts/Locations and Study Status
9 January 7, 2021 Study Status
10 March 22, 2021 Recruitment Status, Study Status, Study Design, Conditions and Study Identification
11 April 1, 2021 Study Status
12 May 18, 2022 Recruitment Status and Study Status
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Study NCT04378777
Submitted Date:  May 6, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: DAIT-COVID-19-002
Brief Title: Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) (IMPACC)
Official Title: A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Recruiting
Study Start: May 1, 2020
Primary Completion: December 2020 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: May 1, 2020
First Submitted that
Met QC Criteria:
May 6, 2020
First Posted: May 7, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 6, 2020
Last Update Posted: May 7, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators: Benaroya Research Institute
Boston Children's Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
observational cohort surveillance study
immunologic assessments
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description:
  • nasal secretion samples
  • whole blood
  • sputum secretions by endotracheal aspiration (for intubated patients)
Enrollment: 2000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Mortality Rate Among COVID-19 Patients
[ Time Frame: Day 1 to Day 28 ]

The incidence of mortality in the first 28 days.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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 Outcome Measures:
1. Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28
[ Time Frame: Day 1 to Day 28 ]

A measure of disease morbidity.
2. 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
[ Time Frame: Day 1 to Day 28 ]

A measure of disease morbidity.
3. Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28
[ Time Frame: Day 1 to Day 28 ]

A measure of disease morbidity.
4. 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
[ Time Frame: Up to 12 Months ]

Method of immune profiling and quantitating the response to COVID-19 over time.
5. Mechanistic: Gene Expression (Transcriptomics) in Blood
[ Time Frame: Up to 12 Months ]

To identify and quantitate differences in immune response associated with disease outcome.
6. Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium
[ Time Frame: Up to 12 Months ]

To identify and quantitate differences in immune response associated with disease outcome.
7. Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein
[ Time Frame: Up to 12 Months ]

To identify and quantitate differences in immune response associated with disease outcome.
8. Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling
[ Time Frame: Up to 12 Months ]

To identify and quantitate differences in immune response associated with disease outcome.
9. Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology
[ Time Frame: Up to 12 Months ]

Circulating immune biomarkers will be explored by use of the OLINK® (name of brand), a multiplex protein biomarker discovery panel.
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Study Officials: Nadine Rouphael, M.D.
Study Chair
Emory University
Locations: United States, California
University of California, Los Angeles: Department of Medicine
[Not yet recruiting]
Los Angeles, California, United States, 90024
Contact:Contact: Joanna M. Schaenman, MD, PhD 310-206-7663 jschaenman@mednet.ucla.edu
Contact:Principal Investigator: Elaine Reed, PhD
University of California San Francisco School of Medicine
[Recruiting]
San Francisco, California, United States, 94115
Contact:Contact: Alejandra Jauregui 415-476-6007 Alejandra.Jauregui@ucsf.edu
Contact:Principal Investigator: Carolyn S. Calfee, MD, MAS
Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
[Recruiting]
Stanford, California, United States, 94305
Contact:Contact: Hena Din, MPH 650-724-7253 henadin@stanford.edu
Contact:Principal Investigator: Kari C. Nadeau, MD, PhD
United States, Connecticut
Yale School of Medicine
[Recruiting]
New Haven, Connecticut, United States, 06520
Contact:Contact: Allison Nelson 203-737-4739 Allison.nelson@yale.edu
Contact:Principal Investigator: Albert C. Shaw, MD
United States, Georgia
Emory University School of Medicine
[Recruiting]
Atlanta, Georgia, United States, 30317
Contact:Contact: Laurel Bristow 925-899-4516 laurel.bristow@emory.edu
Contact:Principal Investigator: Nadine Rouphael, MD
United States, Massachusetts
Brigham and Women's Hospital
[Recruiting]
Boston, Massachusetts, United States, 02115
Contact:Contact: Karina Oganezova 617-732-8624 koganezova@bwh.harvard.edu
Contact:Contact: Hannah Jin hjin5@bwh.harvard.edu
Contact:Principal Investigator: Lindsey R. Baden, MD
United States, New York
Icahn School of Medicine at Mount Sinai
[Recruiting]
New York, New York, United States, 10029
Contact:Contact: Komal Srivastava 212-241-6605 Komal.Srivastava@mountsinai.org
Contact:Principal Investigator: Viviana A. Simon, MD, PhD
United States, Ohio
University Hospitals Case Medical Center
[Not yet recruiting]
Cleveland, Ohio, United States, 44106
Contact:Contact: Jennifer Sustin 216-368-2797 Jennifer.sustin@case.edu
Contact:Principal Investigator: Grace McComsey, MD
United States, Oregon
Oregon Health & Science University
[Recruiting]
Portland, Oregon, United States, 97239
Contact:Contact: Sarah Siegel 503-484-2185 siegels@ohsu.edu
Contact:Principal Investigator: William B. Messer, MD, PhD
United States, Pennsylvania
Drexel University College of Medicine
[Recruiting]
Philadelphia, Pennsylvania, United States, 19102
Contact:Contact: Mariana Bernui 267-507-6554 mb3532@drexel.edu
Contact:Principal Investigator: Charles B. Cairns, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: National Institute of Allergy and Infectious Diseases
Description: Division of Allergy, Immunology, and Transplantation
Available IPD/Information:

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