SARS-CoV-2 Clinical Trial
— IMPACCOfficial title:
A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19 (DAIT-COVID-19-002)
Verified date | May 2022 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1227 |
Est. completion date | April 21, 2022 |
Est. primary completion date | March 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | University of Texas at Austin: UT Health Austin | Austin | Texas |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
United States | University of Florida Health Gainesville | Gainesville | Florida |
United States | Baylor College of Medicine: Department of Medicine | Houston | Texas |
United States | University of Florida Health Jacksonville | Jacksonville | Florida |
United States | University of California, Los Angeles: Department of Medicine | Los Angeles | California |
United States | Yale School of Medicine | New Haven | Connecticut |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | University of Oklahoma ,Oklahoma Health Sciences Center: Pulmonary/Critical Care, Department of Medicine | Oklahoma City | Oklahoma |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
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 | University of South Florida Health Tampa | Tampa | Florida |
United States | University of Arizona (UA) College of Medicine - Tucson: UA Health Sciences Asthma and Airway Disease Research Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Benaroya Research Institute, Boston Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality Rate Among COVID-19 Patients | The incidence of mortality in the first 28 days. | Day 1 to Day 28 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28 | Collected as part of clinical care. | Day 1 to Day 28 | |
Primary | 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 | Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28 | A measure of disease morbidity. | Day 1 to Day 28 | |
Secondary | 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. | Day 1 to Day 28 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Mechanistic: Gene Expression (Transcriptomics) in Blood | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months | |
Secondary | Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months | |
Secondary | Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months | |
Secondary | Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling | To identify and quantitate differences in immune response associated with disease outcome. | Up to 12 Months | |
Secondary | 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 |
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