Phase 3
N=511
Convalescent Plasma in Outpatients With COVID-19
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04355767 ↗Enrolled (actual)
511
Serious AEs
24.1%
Results posted
Oct 2021
Primary outcome: Primary: Number of Patients With Disease Progression (Intention-to-treat Population) — 77; 81; 51; 56 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Convalescent Plasma (Biological); Saline (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Disease Progression (Intention-to-treat Population) |
77; 81; 51; 56; 25; 25 | — |
| PRIMARY Number of Patients With Disease Progression (Per-protocol Population) |
71; 80; 47; 55; 24; 25 | — |
| SECONDARY Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization |
55; 55; 141; 133; 12; 17 | — |
| SECONDARY Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression |
107; 116 | — |
| SECONDARY Number of Hospital-free Days During the 30 Days Following Randomization |
28.3; 28.6 | — |
| SECONDARY All-cause Mortality |
5; 1 | — |
Summary
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Eligibility Criteria
Inclusion Criteria
- One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
- Has at least one study defined risk factor for severe COVID-19 illness
- Clinical team deems stable for outpatient management without supplemental oxygen
- CP available at the site at the time of enrollment
- Duration of symptoms ≤ 7 days at ED presentation
- Informed consent from subject
Exclusion Criteria
- Age less than 18 years
- Prisoner or ward of the state
- Presumed unable to complete follow-up assessments
- Prior adverse reaction(s) from blood product transfusion
- Receipt of any blood product within the past 120 days
- Treating clinical team unwilling to administer 300 ml fluid
- Enrollment in another interventional trial for COVID-19 illness
Data sourced from ClinicalTrials.gov (NCT04355767). 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.