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Outpatient convalescent plasma therapy for high-risk patients with early COVID-19: a randomized placebo-controlled
Arvind Gharbharan1, Carlijn Jordans1, Lisa Zwaginga2
1Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
Insights
Convalescent plasma (CP) therapy did not improve disease severity in high-risk COVID-19 outpatients treated early. This study found no significant benefit of CP for reducing hospital admissions or symptom duration in this patient group.
Area of Science:
- Infectious Diseases
- Immunology
- Critical Care Medicine
Background:
- Early administration of convalescent plasma (CP) is theorized to be most beneficial for coronavirus disease 2019 (COVID-19).
- High-risk outpatients with COVID-19 require effective early interventions to prevent disease progression.
Purpose of the Study:
- To evaluate the effectiveness of convalescent plasma (CP) therapy in improving the clinical course of COVID-19 among high-risk outpatients.
- To assess the impact of CP on disease severity, hospital admission, and viral RNA excretion in early COVID-19.
Main Methods:
- A multicentre, double-blind randomized trial comparing CP with non-CP in symptomatic outpatients (≥50 years, symptom duration <8 days) with confirmed COVID-19 and at least one risk factor for severe disease.
- The primary endpoint was a 5-point ordinal disease severity score assessed over 28 days, with secondary endpoints including hospital admission, symptom duration, and viral RNA excretion.
Main Results:
- Recruitment was halted early due to high vaccination uptake. Of 416 transfused patients, 28 were hospitalized and two died within 28 days.
- Convalescent plasma (CP) showed an odds ratio of 0.86 (95% CI, 0.59-1.22) for improved disease severity, with a more pronounced, though not statistically significant, effect in patients with symptom duration ≤5 days (OR 0.58).
- No significant differences were observed in hospital admission rates (HR 0.61), viral RNA excretion, or symptom duration between the CP and non-CP groups.
Conclusions:
- Convalescent plasma (CP) therapy did not demonstrate a significant benefit in improving the 5-point disease severity score for patients with early-stage COVID-19.
- The findings suggest that CP may not be an effective treatment for high-risk outpatients with early COVID-19, especially in the context of widespread vaccination.
Objectives:
The potential benefit of convalescent plasma (CP) therapy for coronavirus disease 2019 (COVID-19) is highest when administered early after symptom onset. Our objective was to determine the effectiveness of CP therapy in improving the disease course of COVID-19 among high-risk outpatients.
Methods:
A multicentre, double-blind randomized trial was conducted comparing 300 mL of CP with non-CP. Patients were ≥50 years, were symptomatic for <8 days, had confirmed RT-PCR or antigen test result for COVID-19 and had at least one risk factor for severe COVID-19. The primary endpoint was the highest score on a 5-point ordinal scale ranging from fully recovered (score = 1) or not (score = 2) on day 7, over hospital admission (score = 3), intensive care unit admission (score = 4) and death (score = 5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion.
Results:
After the enrolment of 421 patients and the transfusion in 416 patients, recruitment was discontinued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60 years, symptoms for 5 days, and 207 of 416 patients received CP therapy. During the 28 day follow-up, 28 patients were hospitalized and two died. The OR for an improved disease severity score with CP was 0.86 (95% credible interval, 0.59-1.22). The OR was 0.58 (95% CI, 0.33-1.02) for patients with ≤5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95% CI, 0.28-1.34). No difference was found in viral RNA excretion or in the duration of symptoms.
Conclusions:
In patients with early COVID-19, CP therapy did not improve the 5-point disease severity score.
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