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Coronavirus Disease 2019 (COVID-19)IMPACCNCT04378777

Immunophenotyping Assessment in a COVID-19 Cohort

An observational study of Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biological sample collection and Data Collection: Clinical Care Assessments
Type of treatment
Surgery or procedure
How many people
1,227 participants
Where
17 sitesUnited States
Study dates
1 May 2020to 21 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30317

  • University of Texas at Austin: UT Health Austin

    Austin, Texas, 78712

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • University of Florida Health Gainesville

    Gainesville, Florida, 32608

  • Baylor College of Medicine: Department of Medicine

    Houston, Texas, 77030

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • University of California, Los Angeles: Department of Medicine

    Los Angeles, California, 90024

  • Yale School of Medicine

    New Haven, Connecticut, 06520

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine

    Oklahoma City, Oklahoma, 73126

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California San Francisco School of Medicine

    San Francisco, California, 94115

  • Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research

    Stanford, California, 94305

  • University of South Florida Health Tampa

    Tampa, Florida, 33606

  • University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Biological sample collection, Data Collection: Clinical Care Assessments
Keywords
observational cohort surveillance study, immunologic assessments
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological sample collectionProcedure or surgery

    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 AssessmentsProcedure or surgery

    Also called Baseline data, 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.

Study groups in NCT04378777
Study groupRoleWhat they receive
Surveillance cohortCohort 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.
Receives: Procedure: Biological sample collection; Procedure: Data Collection: Clinical Care Assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality Rate Among COVID-19 Patients

    The incidence of mortality in the first 28 days.

    Measured: Day 1 to Day 28

  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

    As a measure of disease acuity and severity.

    Measured: Day 1 to Day 28

  3. 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.

    Measured: Day 1 to Day 28

  4. 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.

    Measured: Day 1 to Day 28

  5. 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.

    Measured: Up to 12 Months

  6. Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28

    Collected as part of clinical care.

    Measured: Day 1 to Day 28

  7. Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28

    Collected as part of clinical care.

    Measured: Day 1 to Day 28

Secondary outcomes (9)

  1. Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28

    A measure of disease morbidity.

    Measured: Day 1 to Day 28

  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

    A measure of disease morbidity.

    Measured: Day 1 to Day 28

  3. Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28

    A measure of disease morbidity.

    Measured: Day 1 to Day 28

  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

    Method of immune profiling and quantitating the response to COVID-19 over time.

    Measured: Up to 12 Months

  5. Mechanistic: Gene Expression (Transcriptomics) in Blood

    To identify and quantitate differences in immune response associated with disease outcome.

    Measured: Up to 12 Months

  6. Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium

    To identify and quantitate differences in immune response associated with disease outcome.

    Measured: Up to 12 Months

  7. Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein

    To identify and quantitate differences in immune response associated with disease outcome.

    Measured: Up to 12 Months

  8. Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling

    To identify and quantitate differences in immune response associated with disease outcome.

    Measured: Up to 12 Months

  9. 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.

    Measured: Up to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start1 May 2020
  3. Primary completion19 Mar 2021
  4. Study completion21 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378777
Sponsor's protocol ID
DAIT-COVID-19-002
Other IDs
NIAID CRMS ID#: 38733
Acronym
IMPACC
Status last verified
May 2022
First submitted
1 May 2020
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gabernet G, Maciuch J, Gygi JP, Moore JF, Hoch A, Syphurs C, Chu T, Doni Jayavelu N, Corry DB, Kheradmand F, Baden LR, Sekaly RP, McComsey GA, Haddad EK, Cairns CB, Rouphael N, Fernandez-Sesma A, Simon V, Metcalf JP, Agudelo Higuita NI, Hough CL, Messer WB, Davis MM, Nadeau KC, Pulendran B, Kraft M, Bime C, Reed EF, Schaenman J, Erle DJ, Calfee CS, Atkinson MA, Brakenridge SC, Melamed E, Shaw AC, Hafler DA, Augustine AD, Becker PM, Ozonoff A, Bosinger SE, Eckalbar W, Maecker HT, Kim-Schulze S, Steen H, Krammer F, Westendorf K; IMPACC Network; Peters B, Fourati S, Altman MC, Levy O, Smolen KK, Montgomery RR, Diray-Arce J, Kleinstein SH, Guan L, Ehrlich LI. A multiomics recovery factor predicts long COVID in the IMPACC study. J Clin Invest. 2025 Sep 9;135(21):e193698. doi: 10.1172/JCI193698. eCollection 2025 Nov 3.

    PubMed 40924481

  • Gygi JP, Maguire C, Patel RK, Shinde P, Konstorum A, Shannon CP, Xu L, Hoch A, Jayavelu ND, Haddad EK; IMPACC Network; Reed EF, Kraft M, McComsey GA, Metcalf JP, Ozonoff A, Esserman D, Cairns CB, Rouphael N, Bosinger SE, Kim-Schulze S, Krammer F, Rosen LB, van Bakel H, Wilson M, Eckalbar WL, Maecker HT, Langelier CR, Steen H, Altman MC, Montgomery RR, Levy O, Melamed E, Pulendran B, Diray-Arce J, Smolen KK, Fragiadakis GK, Becker PM, Sekaly RP, Ehrlich LI, Fourati S, Peters B, Kleinstein SH, Guan L. Integrated longitudinal multiomics study identifies immune programs associated with acute COVID-19 severity and mortality. J Clin Invest. 2024 May 1;134(9):e176640. doi: 10.1172/JCI176640.

    PubMed 38690733

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality Rate Among COVID-19 Patients (time frame: Day 1 to Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.

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