Phase 2
N=223
Plasma Therapy of COVID-19 in Severely Ill Patients
SARS-CoV-2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04359810 ↗Enrolled (actual)
223
Serious AEs
29.7%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status — 108; 48; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Convalescent Plasma (anti-SARS-CoV-2 plasma) (Biological); Non-convalescent Plasma (control plasma) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Max O'Donnell
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status |
108; 48; 3; 2; 7; 1 | — |
| SECONDARY Proportion of SARS-CoV-2 PCR Positivity |
— | — |
| SECONDARY Levels of SARS-CoV-2 RNA |
— | — |
| SECONDARY Duration of Need for Supplemental Oxygen |
6; 7 | — |
| SECONDARY Duration of Hospitalization |
9; 8 | — |
| SECONDARY 28-day Mortality |
19; 18 | — |
| SECONDARY Time-to-clinical Improvement In-hospital |
5; 7 | — |
| SECONDARY Host Genetic Differences at Day 0 |
— | — |
| SECONDARY Host Transcriptomic Differences at Days 0,7,14 |
— | — |
Summary
This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
- Age ≥18 years
- Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
- Evidence of infiltrates on chest radiography
- Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.
Exclusion Criteria
- Participation in another clinical trial of anti-viral agent(s) for COVID-19
- Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration [1]
- Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
- Severe multi-organ failure
- History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
- Known Immunoglobulin A (IgA) deficiency
- Females who are pregnant
- Use of remdesivir as treatment for COVID-19 is permitted.
Data sourced from ClinicalTrials.gov (NCT04359810). 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.