COVID-19 Clinical Trial
— PassItOnOfficial title:
Passive Immunity Trial for Our Nation (PassItOn)
Verified date | October 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Status | Completed |
Enrollment | 974 |
Est. completion date | August 6, 2021 |
Est. primary completion date | July 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Currently hospitalized or in an emergency department with anticipated hospitalization 3. Symptoms of acute respiratory infection, defined as one or more of the following: 1. Cough 2. Chills, or a fever (greater than 37.5° C or 99.5° F) 3. Shortness of breath, operationalized as a patient having any of the following: i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy 4. Laboratory-confirmed SARS-CoV-2 infection within the past 14 days Exclusion Criteria: 1. Prisoner 2. Unable to randomize within 14 days after onset of acute respiratory infection symptoms 3. Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.) 4. Inability to be contacted on Day 29-36 for clinical outcome assessment 5. Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days 6. Contraindications to transfusion or history of prior reactions to transfused blood products 7. Plan for hospital discharge within 24 hours of enrollment 8. Previous enrollment in this trial 9. Previous laboratory-confirmed SARS-CoV-2 infection before the current illness 10. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy 11. Prior receipt of SARS-CoV-2 vaccine |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
United States | University of Colorado Denver | Aurora | Colorado |
United States | University of Maryland, Baltimore (University of Maryland Medical Center) | Baltimore | Maryland |
United States | Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | University at Buffalo/Buffalo General Medical Center | Buffalo | New York |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic Ohio | Cleveland | Ohio |
United States | The Ohio State University Wexner Medical Center and James Cancer Hospital | Columbus | Ohio |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | The University of Kansas Medical Center | Kansas City | Kansas |
United States | Scripps Health | La Jolla | California |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Meharry Medical College | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Newton-Wellelsey Hospital | Newton | Massachusetts |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Utah Valley Hospital | Provo | Utah |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Rochester General Hospital | Rochester | New York |
United States | University of Utah Health | Salt Lake City | Utah |
United States | University of Washington | Seattle | Washington |
United States | MedStar Health Research Institute/MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Dolly Parton, National Center for Advancing Translational Sciences (NCATS) |
United States,
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* Note: There are 50 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acute Kidney Injury | Number of participants with Acute kidney injury | Baseline to Day 28 | |
Other | Renal Replacement Therapy | Number of participants requiring renal replacement therapy | Baseline to Day 28 | |
Other | Documented Venous Thromboembolic Disease (DVT or PE) | Number of participants with documented venous thromboembolic disease (DVT or PE) | Baseline to Day 28 | |
Other | Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke) | Number of Participants with myocardial infarction or ischemic stroke | Baseline to Day 28 | |
Other | Transfusion Reaction | Number of participants with transfusion reaction (fever/rash) | Baseline to Day 28 | |
Other | Transfusion Related Acute Lung Injury (TRALI) | Number of participants with transfusion related acute lung injury (TRALI) | Baseline to Day 28 | |
Other | Transfusion Associated Circulatory Overload (TACO) | Number of participants with transfusion associated circulatory overload (TACO) | Baseline to Day 28 | |
Other | Transfusion Related Infection | Number of participants with transfusion related infection | Baseline to Day 28 | |
Primary | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death |
Study Day 15 | |
Secondary | All-location, All-cause 14-day Mortality | All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review | Baseline to Study Day 14 | |
Secondary | All-location, All-cause 28-day Mortality | All-location, all-cause 28-day mortality | Baseline to Study Day 28 | |
Secondary | Survival Through 28 Days | Number of participants survived through Day 28 | Baseline to Day 28 (assessed on Study Day 29) | |
Secondary | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death |
Baseline to Study Day 3 | |
Secondary | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death |
Study Day 8 | |
Secondary | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death |
Study Day 29 | |
Secondary | Oxygen-free Days Through Day 28 | Number of days without use of oxygen | Baseline to Day 28 | |
Secondary | Ventilator-free Days Through Day 28 | Number of days without use of a ventilator | Baseline to Day 28 | |
Secondary | Vasopressor-free Days Through Day 28 | Number of days without use of vasopressors | Baseline to Day 28 | |
Secondary | ICU-free Days Through Day 28 | Number of days outside of ICU | Baseline to Day 28 | |
Secondary | Hospital-free Days Through Day 28 | Number of days outside of the hospital | Baseline to Day 28 |
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Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
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N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
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