A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19

Abstract

A single center open label phase 2 randomised control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess clinical and immunological benefits of passive immunization using convalescent plasma therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 patients hospitalized with severe COVID-19 disease were recruited and randomized into either standard of care (SOC, N = 40) or convalescent plasma therapy (CPT, N = 40). Primary outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of response to therapy, for which plasma abundance of a large panel of cytokines was quantitated before and after intervention. The trial found that all-cause mortality was not significantly different among severe COVID-19 patients with ARDS randomized to the two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% CI 0.3010–1.505, P = 0.3424). No adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS no significant clinical benefit was registered in this clinical trial with convalescent plasma therapy in terms of prespecified outcomes.

BibTeX

@article{ray2022phase2,
  title={A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19},
  author={Yogiraj Ray and Shekhar Ranjan Paul and Purbita Bandopadhyay and Ranit D'Rozario and Jafar Sarif and Deblina Raychaudhuri and Debaleena Bhowmik and Abhishake Lahiri and Janani Srinivasa Vasudevan and Ranjeet Maurya and others},
  journal={Nature Communications},
  year={2022},
  doi={10.1038/s41467-022-28064-7},
  abstract={A single center open label phase 2 randomised control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess clinical and immunological benefits of passive immunization using convalescent plasma therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 patients hospitalized with severe COVID-19 disease were recruited and randomized into either standard of care (SOC, N = 40) or convalescent plasma therapy (CPT, N = 40). Primary outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of response to therapy. The trial found that all-cause mortality was not significantly different among severe COVID-19 patients with ARDS randomized to the two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% CI 0.3010-1.505, P = 0.3424). No adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS no significant clinical benefit was registered in this clinical trial with convalescent plasma therapy in terms of prespecified outcomes.}
}