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| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 38733 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Benaroya Research Institute | OTHER |
| Boston Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28 | A measure of disease morbidity. | 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 |
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Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Rouphael, M.D. | Emory University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40924481 | Derived | 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. | |
| 38690733 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases | View source |
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| 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. |
|
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| Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28 | Collected as part of clinical care. | Day 1 to Day 28 |
A measure of disease morbidity. |
| Day 1 to Day 28 |
| Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28 | A measure of disease morbidity. | 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 | Method of immune profiling and quantitating the response to COVID-19 over time. | Up to 12 Months |
| Mechanistic: Gene Expression (Transcriptomics) in Blood | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months |
| Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months |
| Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months |
| Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months |
| Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology | Circulating immune biomarkers will be explored by use of the OLINKĀ® (name of brand), a multiplex protein biomarker discovery panel. | Up to 12 Months |
| University of California, Los Angeles: Department of Medicine | Los Angeles | California | 90024 | United States |
| University of California San Francisco School of Medicine | San Francisco | California | 94115 | United States |
| Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research | Stanford | California | 94305 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| University of Florida Health Gainesville | Gainesville | Florida | 32608 | United States |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of South Florida Health Tampa | Tampa | Florida | 33606 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30317 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine | Oklahoma City | Oklahoma | 73126 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| University of Texas at Austin: UT Health Austin | Austin | Texas | 78712 | United States |
| Baylor College of Medicine: Department of Medicine | Houston | Texas | 77030 | United States |
| 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. |
| Division of Allergy, Immunology, and Transplantation | View source |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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