Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

Area of Science:

• Infectious Diseases
• Immunology
• Critical Care Medicine

Background:

• The efficacy of convalescent plasma (CP) therapy for hospitalized patients with coronavirus disease 2019 (COVID-19) remains inconclusive.
• This study aimed to clarify the impact of CP on clinical improvement in this patient population.

Purpose of the Study:

• To investigate the effectiveness of convalescent plasma (CP) in enhancing clinical improvement among hospitalized COVID-19 patients.
• To compare the outcomes of CP plus standard of care (SOC) versus SOC alone in a randomized trial.

Main Methods:

• An investigator-initiated, randomized, parallel-arm, open-label, superiority clinical trial was conducted.
• 160 hospitalized COVID-19 patients were randomized (1:1) to receive either two infusions of CP plus SOC or SOC alone.
• The primary outcome was the proportion of patients showing clinical improvement 28 days post-enrollment.

Main Results:

• No significant difference in clinical improvement was observed between the CP+SOC group (61.3%) and the SOC alone group (65.0%) at 28 days.
• Subgroup analyses for severe and critically ill patients yielded similar results.
• Secondary outcomes, including 28-day mortality and respiratory support requirements, showed no significant differences between the groups.

Conclusions:

• Convalescent plasma therapy, when added to standard of care, did not lead to a higher proportion of clinical improvement in hospitalized COVID-19 patients compared to standard of care alone.
• The findings suggest that CP therapy may not be an effective treatment for improving clinical outcomes in this patient cohort.