Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Condition: COVID-19; Coronavirus; SARS-CoV-2
MeSH terms: COVID-19
Intervention: pathogen reduced SARS-CoV-2 convalescent plasma; Placebo
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 974.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19 drug treatment; convalescent plasma

Summary:

      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.
    

Eligibility criteria:

        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