Immunophenotyping Assessment in a COVID-19 Cohort

NCT04378777 | Completed

• 2 other identifiers: DAIT-COVID-19-002NIAID CRMS ID#: 38733
• Study Type: observational
• Target: 1,227
• Locations: 1 country
• Sites: 17

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.

Conditions

Coronavirus Disease 2019 (COVID-19); SARS-CoV-2

Keywords

observational cohort surveillance study; immunologic assessments

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

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

  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

  Day 1 to Day 28

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

  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

  Up to 12 Months

• Mechanistic: Gene Expression (Transcriptomics) in Blood

  Up to 12 Months

Study Arms (1)

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; Procedure: Data Collection: Clinical Care Assessments

Interventions

Biological sample collection PROCEDURE

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.

Surveillance cohort

Data Collection: Clinical Care Assessments PROCEDURE

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.

Also known as: Baseline data, clinical care assessments

Surveillance cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Benaroya Research Institute: collaborator
• Boston Children's Hospital: collaborator

Study Sites (17)

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

Tucson, Arizona, 85724, United States

Location

University of California, Los Angeles: Department of Medicine

Los Angeles, California, 90024, United States

Location

University of California San Francisco School of Medicine

San Francisco, California, 94115, United States

Location

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

Stanford, California, 94305, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Florida Health Gainesville

Gainesville, Florida, 32608, United States

Location

University of Florida Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of South Florida Health Tampa

Tampa, Florida, 33606, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30317, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

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

Oklahoma City, Oklahoma, 73126, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

University of Texas at Austin: UT Health Austin

Austin, Texas, 78712, United States

Location

Baylor College of Medicine: Department of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 40924481 DERIVED

• 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.

  PMID: 38690733 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

* nasal secretion samples * whole blood * sputum secretions by endotracheal aspiration (for intubated patients)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nadine Rouphael, M.D.

  Emory University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 7, 2020
• Study Start: May 1, 2020
• Primary Completion: March 19, 2021
• Study Completion: April 21, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

US (17)