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Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378777
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : May 19, 2022
Sponsor:
Collaborators:
Benaroya Research Institute
Boston Children's Hospital
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date May 1, 2020
First Posted Date May 7, 2020
Last Update Posted Date May 19, 2022
Actual Study Start Date May 1, 2020
Actual Primary Completion Date March 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2020)
  • Mortality Rate Among COVID-19 Patients [ Time Frame: Day 1 to Day 28 ]
    The incidence of mortality in the first 28 days.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • Mechanistic: Gene Expression (Transcriptomics) in Blood [ Time Frame: Up to 12 Months ]
    To identify and quantitate differences in immune response associated with disease outcome.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • nasal secretion samples
  • whole blood
  • sputum secretions by endotracheal aspiration (for intubated patients)
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.
Condition
  • Coronavirus Disease 2019 (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.
  • 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 Name: Baseline data, clinical care assessments
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Biological sample collection
  • Procedure: Data Collection: Clinical Care Assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2021)
1227
Original Estimated Enrollment
 (submitted: May 6, 2020)
2000
Actual Study Completion Date April 21, 2022
Actual Primary Completion Date March 19, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04378777
Other Study ID Numbers DAIT-COVID-19-002
NIAID CRMS ID#: 38733 ( Other Identifier: DAIT NIAID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Original Responsible Party Same as current
Current Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Original Study Sponsor Same as current
Collaborators
  • Benaroya Research Institute
  • Boston Children's Hospital
Investigators
Study Chair: Nadine Rouphael, M.D. Emory University
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2022