A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia
Abstract
BACKGROUND
Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is inconclusive.
METHODS
We conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (non-invasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7(death) at 14 days, and primary analysis was performed in the intention-to-treat population.
RESULTS
Between April 4, 2020 and February 5, 2021, 350 patients were randomly assigned to either CP (n=179) or SOC (n=171). At 14 days, proportion of patients on categories 5, 6 or 7 was 11.7% in CP group versus 16.4% in control group (p=0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in CP group versus 17.0% in control group (p=0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95%CI 0.19-1.14, log-rank p=0.087).
CONCLUSION
CP showed a significant benefit in preventing progression to non-invasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 179 participants or records.
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