Abstract
Objectives
The potential benefit of convalescent plasma (CP) therapy for COVID-19 is highest when given early after symptom onset. Our objective was to determine the effectiveness of CP in improving the disease course of COVID-19 in high-risk outpatients.
Methods
A multicentre double blind randomized trial was conducted comparing 300mL of CP with non-CP. Patients were 50 years or older, symptomatic for <8 days, had PCR or antigen-test confirmed COVID-19 and at least 1 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 (2) on day 7, over hospital admission (3), ICU admission (4) and death (5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion.
Results
After enrolment of 421 patients and the transfusion of 416, recruitment was discontinued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60, symptoms for 5 days and 207 of 416 received CP. During the 28 days of follow-up, 28 patients were hospitalized and 2 died. The odds ratio (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%confidence interval 0.33–1.02) for patients with ≤5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95%confidence interval 0.28-1.34). No difference was found in viral RNA excretion nor in the duration of symptoms.
Conclusions
In patients with early COVID-19, CP did not improve the 5-point disease severity score.
Clinical registry number
NCT04589949.
【저자키워드】 COVID-19, convalescent plasma, antibodies, outpatients, 【초록키워드】 vaccination, Hospitalized, randomization, severe COVID-19, disease severity, randomized trial, Symptom, risk factor, Symptoms, RNA, PCR, symptom duration, symptomatic, clinical, Patient, Effectiveness, ICU admission, death, double blind, multicentre, Hospital admission, Viral RNA, Follow-up, recruitment, primary endpoint, Odds ratio, symptom onset, Older, Endpoint, hazard ratio, median age, enrolment, objective, benefit, secondary, IMPROVE, Course, Result, highest, died, the disease, conducted, determine, in viral, duration of symptoms, therapy for COVID-19, 【제목키워드】 Convalescent plasma therapy, Outpatient, randomized placebo-controlled trial, high-risk patient,