We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Coronavirus Disease 2019 (COVID-19) SARS-CoV-2 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1227 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : March 19, 2021
Actual Study Completion Date : April 21, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Baseline data, clinical care assessments


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Biospecimen Retention:   Samples With DNA
  • nasal secretion samples
  • whole blood
  • sputum secretions by endotracheal aspiration (for intubated patients)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378777


Locations
Show Show 17 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Benaroya Research Institute
Boston Children's Hospital
Investigators
Layout table for investigator information
Study Chair: Nadine Rouphael, M.D. Emory University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04378777    
Other Study ID Numbers: DAIT-COVID-19-002
NIAID CRMS ID#: 38733 ( Other Identifier: DAIT NIAID )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
observational cohort surveillance study
immunologic assessments
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases