Phase 3
N=974
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
COVID-19 · Coronavirus · SARS-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04362176 ↗Enrolled (actual)
974
Serious AEs
3.8%
Results posted
Nov 2022
Primary outcome: Primary: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score — 150; 144; 157; 167 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pathogen reduced SARS-CoV-2 convalescent plasma (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score |
150; 144; 157; 167; 16; 11 | — |
| SECONDARY All-location, All-cause 14-day Mortality |
63; 48 | — |
| SECONDARY All-location, All-cause 28-day Mortality |
89; 80 | — |
| SECONDARY Survival Through 28 Days |
393; 385 | — |
| SECONDARY COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 |
1; 6; 49; 54; 42; 49 | — |
| SECONDARY COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 |
95; 110; 130; 125; 31; 16 | — |
| SECONDARY COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 |
183; 204; 168; 144; 7; 7 | — |
| SECONDARY Oxygen-free Days Through Day 28 |
21; 21 | — |
| SECONDARY Ventilator-free Days Through Day 28 |
28; 28 | — |
| SECONDARY Vasopressor-free Days Through Day 28 |
28; 28 | — |
| SECONDARY ICU-free Days Through Day 28 |
28; 28 | — |
| SECONDARY Hospital-free Days Through Day 28 |
20; 21 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT04362176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.