Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (PassItOn)
COVID-19, Coronavirus, SARS-CoV-2
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 drug treatment, convalescent plasma
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 18 years
- Currently hospitalized or in an emergency department with anticipated hospitalization
Symptoms of acute respiratory infection, defined as one or more of the following:
- Cough
- Chills, or a fever (greater than 37.5° C or 99.5° F)
- 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
- Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
Exclusion Criteria:
- Prisoner
- Unable to randomize within 14 days after onset of acute respiratory infection symptoms
- 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.)
- Inability to be contacted on Day 29-36 for clinical outcome assessment
- Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
- Contraindications to transfusion or history of prior reactions to transfused blood products
- Plan for hospital discharge within 24 hours of enrollment
- Previous enrollment in this trial
- Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
- Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
- Prior receipt of SARS-CoV-2 vaccine
Sites / Locations
- University of Arkansas for Medical Sciences
- Scripps Health
- University of Colorado Denver
- MedStar Health Research Institute/MedStar Washington Hospital Center
- Cleveland Clinic Florida
- University of Chicago
- Loyola University Medical Center
- The University of Kansas Medical Center
- Our Lady of the Lake Regional Medical Center
- University of Maryland, Baltimore (University of Maryland Medical Center)
- Beth Israel Deaconess Medical Center
- Newton-Wellelsey Hospital
- University of Minnesota
- University of Mississippi Medical Center
- University of New Mexico Health Sciences Center
- University at Buffalo/Buffalo General Medical Center
- Rochester General Hospital
- Cleveland Clinic Ohio
- The Ohio State University Wexner Medical Center and James Cancer Hospital
- Vanderbilt University Medical Center
- Meharry Medical College
- Utah Valley Hospital
- University of Utah Health
- Sentara Norfolk General Hospital
- Virginia Commonwealth University
- University of Washington
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
pathogen reduced SARS-CoV-2 convalescent plasma
Placebo
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.