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.
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
974
Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
Lactated Ringer's solution with multivitamins
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: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 15
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
Time frame: Baseline to Study Day 14
All-location, All-cause 28-day Mortality
All-location, all-cause 28-day mortality
Time frame: Baseline to Study Day 28
Survival Through 28 Days
Number of participants survived through Day 28
Time frame: Baseline to Day 28 (assessed on Study Day 29)
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: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
University of Colorado Denver
Aurora, Colorado, United States
MedStar Health Research Institute/MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
University of Maryland, Baltimore (University of Maryland Medical Center)
Baltimore, Maryland, United States
...and 16 more locations
Time frame: Baseline to Study Day 3
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: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 8
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: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 29
Oxygen-free Days Through Day 28
Number of days without use of oxygen
Time frame: Baseline to Day 28
Ventilator-free Days Through Day 28
Number of days without use of a ventilator
Time frame: Baseline to Day 28
Vasopressor-free Days Through Day 28
Number of days without use of vasopressors
Time frame: Baseline to Day 28
ICU-free Days Through Day 28
Number of days outside of ICU
Time frame: Baseline to Day 28
Hospital-free Days Through Day 28
Number of days outside of the hospital
Time frame: Baseline to Day 28