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Clinical and immunological benefits of convalescent plasma therapy in severe COVID-19: insights from a single center open label randomised control trial

Ray et al., medRxiv, doi:10.1101/2020.11.25.20237883
Nov 2020  
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Mortality 33% primary Improvement Relative Risk Conv. Plasma  Ray et al.  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 80 patients in India Lower mortality with convalescent plasma (not stat. sig., p=0.34) c19early.org Ray et al., medRxiv, November 2020 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
Small RCT 80 hospitalized patients in India, 40 treated with convalescent plasma, not showing significant differences in primary analysis. Authors note that significant improvement in hypoxia, reduction in hospital stay, and survival benefit was seen in severe COVID-19 patients with ARDS aged <67. CTRI/2020/05/025209.
risk of death, 33.0% lower, HR 0.67, p = 0.34, treatment 10 of 40 (25.0%), control 14 of 40 (35.0%), NNT 10, adjusted per study, Mantel-Haenszel, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ray et al., 29 Nov 2020, Randomized Controlled Trial, India, peer-reviewed, 37 authors.
This PaperConv. PlasmaAll
Clinical and immunological benefits of convalescent plasma therapy in severe COVID-19: insights from a single center open label randomised control trial
Yogiraj Ray, Shekhar Ranjan Paul, Purbita Bandopadhyay, Ranit D’rozario, Jafar Sarif, Abhishake Lahiri, Debaleena Bhowmik, Janani Srinivasa Vasudevan, Ranjeet Maurya, Akshay Kanakan, Sachin Sharma, Manish Kumar, Praveen Singh, Rammohan Roy, Kausik Chaudhury, Rajsekhar Maiti, Saugata Bagchi, Ayan Maiti, Md. Masoom Perwez, Abhinandan Mondal, Avinash Tewari, Samik Mandal, Arpan Roy, Moumita Saha, Durba Biswas, Chikam Maiti, Sayantan Chakraborty, Biswanath Sharma Sarkar, Anima Haldar, Bibhuti Saha, Shantanu Sengupta, Rajesh Pandey, Shilpak Chatterjee, Prasun Bhattacharya, Sandip Paul, Dipyaman Ganguly
doi:10.1101/2020.11.25.20237883
A single center open label phase II randomised control trial was done to assess the pathogen and host-intrinsic factors influencing clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT), in addition to standard of care (SOC) therapy in severe COVID-19 patients, as compared to patients only on SOC therapy. Methods: Convalescent plasma was collected from patients recovered from COVID-19 following a screening protocol which also included measuring plasma anti SARS-CoV2 spike IgG content. Retrospectively, neutralizing antibody content was measured and proteome was characterized by LC-MS/MS for all convalescent plasma units that were transfused to patients. Severe COVID-19 patients with evidence for acute respiratory distress syndrome (ARDS) with PaO2/FiO2 ratio 100-300 (moderate ARDS) were recruited and randomised into two parallel arms of SOC and CPT, N=40 in each arm. Peripheral blood samples were collected on the day of enrolment (T1) followed by day3/4 (T2) and day 7 (T3). RT-PCR and sequencing was done for SARS-CoV2 RNA isolated from nasopharyngeal swabs collected at T1. A panel of cytokines and neutralizing antibody content were measured in plasma at all three timepoints. Patients were followed up for 30 days post-admission to assess the primary outcomes of all cause mortality and immunological correlates for clinical benefits. Results: While across all age-groups no statistically significant clinical benefit was registered for patients in the CPT arm, significant immediate mitigation of hypoxia, reduction in hospital stay as well as survival benefit was recorded in severe COVID-19 patients with ARDS aged less than 67 years receiving convalescent plasma therapy. In addition to its neutralizing antibody content a prominent effect of convalescent plasma on attenuation of systemic cytokine levels possibly contributed to its benefits. Conclusion: Precise targeting of severe COVID-19 patients is necessary for reaping the clinical benefits of convalescent plasma therapy.
Competing interests The authors declare no competing interests.
References
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Late treatment
is less effective
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