Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults

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