Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1227 participants
OBSERVATIONAL
2020-05-01
2022-04-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Benaroya Research Institute
OTHER
Boston Children's Hospital
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Nadine Rouphael, M.D.
Role: STUDY_CHAIR
Emory University
Locations
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University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center
Tucson, Arizona, United States
University of California, Los Angeles: Department of Medicine
Los Angeles, California, United States
University of California San Francisco School of Medicine
San Francisco, California, United States
Stanford Medicine: Sean N. Parker Center for Allergy & Asthma Research
Stanford, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Florida Health Gainesville
Gainesville, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
University of South Florida Health Tampa
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Texas at Austin: UT Health Austin
Austin, Texas, United States
Baylor College of Medicine: Department of Medicine
Houston, Texas, United States
Countries
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References
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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 LIR. A multi-omics recovery factor predicts long COVID in the IMPACC study. J Clin Invest. 2025 Sep 9:e193698. doi: 10.1172/JCI193698. Online ahead of print.
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.
Related Links
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National Institute of Allergy and Infectious Diseases
Division of Allergy, Immunology, and Transplantation
Other Identifiers
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NIAID CRMS ID#: 38733
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT-COVID-19-002
Identifier Type: -
Identifier Source: org_study_id
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