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Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).


ABSTRACT: OBJECTIVE:To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India. DESIGN:Open label, parallel arm, phase II, multicentre, randomised controlled trial. SETTING:39 public and private hospitals across India. PARTICIPANTS:464 adults (?18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm). INTERVENTIONS:Participants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study. MAIN OUTCOME MEASURE:Composite of progression to severe disease (PaO2/FiO2 <100 mm Hg) or all cause mortality at 28 days post-enrolment. RESULTS:Progression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval -0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54). CONCLUSION:Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19. TRIAL REGISTRATION:Clinical Trial Registry of India CTRI/2020/04/024775.

SUBMITTER: Agarwal A 

PROVIDER: S-EPMC7578662 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).

Agarwal Anup A   Mukherjee Aparna A   Kumar Gunjan G   Chatterjee Pranab P   Bhatnagar Tarun T   Malhotra Pankaj P  

BMJ (Clinical research ed.) 20201022


<h4>Objective</h4>To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.<h4>Design</h4>Open label, parallel arm, phase II, multicentre, randomised controlled trial.<h4>Setting</h4>39 public and private hospitals across India.<h4>Participants</h4>464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of in  ...[more]

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