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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)

BMJ (Online), 2020-10, Vol.371, p.m3939-m3939 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2020 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. BMJ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2020 BMJ ;ISSN: 1756-1833 ;ISSN: 0959-8138 ;EISSN: 1756-1833 ;DOI: 10.1136/bmj.m3939 ;PMID: 33093056

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  • Title:
    Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
  • Author: Agarwal, Anup ; Mukherjee, Aparna ; Kumar, Gunjan ; Chatterjee, Pranab ; Bhatnagar, Tarun ; Malhotra, Pankaj
  • Subjects: Blood pressure ; Coronaviruses ; COVID-19 ; Medical research ; Mortality ; Respiration
  • Is Part Of: BMJ (Online), 2020-10, Vol.371, p.m3939-m3939
  • Description: AbstractObjectiveTo investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.DesignOpen label, parallel arm, phase II, multicentre, randomised controlled trial.Setting39 public and private hospitals across India.Participants464 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).InterventionsParticipants 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 measureComposite of progression to severe disease (PaO2/FiO2 <100 mm Hg) or all cause mortality at 28 days post-enrolment.ResultsProgression 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).ConclusionConvalescent 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 registrationClinical Trial Registry of India CTRI/2020/04/024775.
  • Publisher: London: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 1756-1833
    ISSN: 0959-8138
    EISSN: 1756-1833
    DOI: 10.1136/bmj.m3939
    PMID: 33093056
  • Source: BMJ Open Access Journals
    ProQuest Central
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