Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
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, average treatment delay 8.0 days, trial CTRI/2020/04/024775
Anup Agarwal,1 Aparna Mukherjee,1 Gunjan Kumar,1 Pranab Chatterjee,1 Tarun Bhatnagar,2
Pankaj Malhotra,3 on behalf of the PLACID Trial Collaborators
Clinical Trial and Health
Systems Research Unit, Indian
Council of Medical Research, V
Ramalingaswamy Bhawan, PO
Box 4911, Ansari Nagar, New
Delhi, 110029, India
ICMR School of Public Health,
Indian Council of Medical
Research -National Institute of
Epidemiology, Chennai, Tamil,
Department of Internal
Medicine, Post Graduate Institute
of Medical Education and
Research, Chandigarh, India
Correspondence to: A Mukherjee,
Clinical Trial and Health Systems
Research Unit, Indian Council of
V Ramalingaswamy Bhawan,
PO Box 4911, Ansari Nagar,
New Delhi, 110029, India
Additional material is published
online only. To view please visit
the journal online.
Cite this as: BMJ 2020;371:m3939
Accepted: 12 October 2020
To investigate the effectiveness of using convalescent
plasma to treat moderate coronavirus disease 2019
(covid-19) in adults in India.
Open label, parallel arm, phase II, multicentre,
randomised controlled trial.
39 public and private hospitals across India.
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).
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
WHAT IS ALREADY KNOWN ON THIS TOPIC
As of October 2020, multiple small case series, one large observational study
(>35 000 patients), and three randomised trials have been published on the
utility of convalescent plasma to treat coronavirus disease 2019 (covid-19)
Although the observational studies suggested clinical benefits in recipients of
convalescent plasma, the trials were stopped early and failed to ascertain any
mortality benefit from convalescent plasma treatment in patients with covid-19
WHAT THIS STUDY ADDS
In settings with limited laboratory capacity, convalescent plasma does not
reduce 28 day mortality or progression to severe disease in patients admitted to
hospital with moderate covid-19
Convalescent plasma treatment was associated with earlier resolution of
shortness of breath and fatigue and higher negative conversion of SARS-CoV-2
RNA on day 7 of enrolment
As a potential treatment for patients with moderate covid-19, convalescent
plasma showed limited effectiveness
the bmj | BMJ 2020;371:m3939 | doi: 10.1136/bmj.m3939
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,
is less effective
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