Passive Immunity Trial for Our Nation (PassItOn)
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.
• 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