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Early Convalescent Plasma for High-Risk Outpatients with Covid-19
Frederick K Korley1, Valerie Durkalski-Mauldin1, Sharon D Yeatts1
1From the University of Michigan, Ann Arbor (F.K.K., R.D.D., C.V.H., V.L.W.S., C.F.G., N.L.H., R.S., W.B.), Spectrum Health, Grand Rapids (J.C.R.), and Michigan State University, East Lansing (J.C.R.) - all in Michigan; the Medical University of South Carolina, Charleston (V.D.-M., S.D.Y., L.D.F., E.L.); Stanford University, Palo Alto, CA (K.S., J.M.H., S.J., J.Q.); Vitalant Research Institute, Scottsdale, AZ (L.J.D.); the National Heart, Lung, and Blood Institute, Bethesda, MD (N.E.K.); the University of Pittsburgh, Pittsburgh (A.K., J.F.M., D.J.T., C.W.C.); Harbor-UCLA Medical Center, Los Angeles (K.Y.); Cooper University Hospital, Camden, NJ (C.W.J.); Oregon Health and Science University, Portland (B.K.); Health Partners Methodist Hospital, St. Louis Park, MN (A.B.); and the University of Chicago, Chicago (D.G.B.).
Early convalescent plasma treatment for high-risk COVID-19 patients did not prevent disease progression. This randomized trial found no significant difference in outcomes between patients receiving high-titer antibody plasma and those receiving a placebo.
Area of Science:
- Immunology
- Infectious Diseases
- Clinical Trials
Background:
- Early administration of convalescent plasma (CP) from recovered coronavirus disease 2019 (COVID-19) donors was investigated for its potential to prevent disease progression in high-risk patients.
- Patients with COVID-19 symptoms were targeted for intervention within 7 days of symptom onset.
Purpose of the Study:
- To evaluate the efficacy of high-titer COVID-19 convalescent plasma in preventing disease progression in high-risk outpatients.
- To assess the impact of convalescent plasma on disease severity, hospitalization rates, and mortality.
Main Methods:
- A randomized, multicenter, single-blind trial involving 511 high-risk COVID-19 patients (age ≥50 or with risk factors) treated in the emergency department.
- Participants received either one unit of high-titer SARS-CoV-2 antibody convalescent plasma or a placebo.
- The primary outcome was disease progression within 15 days, defined as hospitalization, urgent care visit, or death without hospitalization.
Main Results:
- Disease progression occurred in 30.0% of the convalescent plasma group and 31.9% of the placebo group (risk difference, 1.9 percentage points).
- No significant differences were observed in the primary outcome, worst illness severity, or hospital-free days between the groups.
- Five deaths occurred in the plasma group and one in the placebo group.
Conclusions:
- Administration of COVID-19 convalescent plasma to high-risk outpatients within one week of symptom onset did not prevent disease progression.
- The findings suggest that this intervention strategy may not be effective for preventing adverse outcomes in this patient population.
