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All Studies   All Outcomes    Recent:   

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

Agarwal et al., BMJ, doi:10.1136/bmj.m3939, PLACID, CTRI/2020/04/024775
Oct 2020  
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Mortality -7% Improvement Relative Risk Combined death at 28 day.. -7% Ventilation 1% Viral clearance 28% Conv. Plasma  PLACID  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 464 patients in India (April - July 2020) Improved viral clearance with convalescent plasma (p=0.02) c19early.org Agarwal et al., BMJ, October 2020 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 464 hospitalized patients in India, 235 treated with convalescent plasma, showing no improvement in combined death at 28 days or progression to severe disease.
risk of death, 7.0% higher, RR 1.07, p = 0.74, treatment 34 of 235 (14.5%), control 31 of 229 (13.5%).
combined death at 28 days or progression to severe disease, 7.0% higher, RR 1.07, p = 0.74, treatment 44 of 235 (18.7%), control 41 of 229 (17.9%).
risk of mechanical ventilation, 1.0% lower, RR 0.99, p = 0.98, treatment 19 of 227 (8.4%), control 19 of 224 (8.5%), NNT 892.
risk of no viral clearance, 28.0% lower, RR 0.72, p = 0.02, treatment 56 of 173 (32.4%), control 76 of 169 (45.0%), NNT 7.9, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Agarwal et al., 22 Oct 2020, Randomized Controlled Trial, India, peer-reviewed, 6 authors, study period 22 April, 2020 - 14 July, 2020, average treatment delay 8.0 days, trial CTRI/2020/04/024775 (PLACID).
This PaperConv. PlasmaAll
Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
Anup Agarwal, Aparna Mukherjee, Gunjan Kumar, Pranab Chatterjee, Tarun Bhatnagar, Pankaj Malhotra
BMJ, doi:10.1136/bmj.m3939
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 (PaO 2 /FiO 2 ) 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 (PaO 2 / FiO 2 <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.
Supplementary information: Additional tables and figures Supplementary information: Detailed list of PLACID Trial collaborators
References
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Joyner, Bruno, Klassen, Safety Update: COVID-19 Convalescent Plasma in 20 000 Hospitalized Patients, Mayo Clin Proc
Joyner, Senefeld, Klassen, Effect of convalescent plasma on mortality among hospitalized patients with covid-19: initial three-month experience, doi:10.1101/2020.08.12.20169359v1.full.pdf
Khan, Hizbullah, Jain, Coronavirus pandemic fuels blackmarket for plasma of recovered patients, India Today
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Late treatment
is less effective
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