The Indian Council of Medical Research (ICMR) has proposed to conduct a clinical trial for ‘randomised evaluation of COVID-19 therapy’ along with the University of Oxford and an expression of intent for participation in it has been sought from hospitals.
The trial — ‘India-UK RECOVERY (Randomised Evaluation of COVID-19 therapy)’ — will be a multi-centre, adaptive platform trial on Covid patients, ICMR said on Friday.
“ICMR, Delhi, along with the University of Oxford is proposing to conduct a multi-centre, adaptive platform trial on COVID-19 patients, titled ‘India-UK RECOVERY (Randomised Evaluation of COVID-19 therapy),” it said.
“An expression of intent is sought from institutions/hospitals with the facilities and capacity available to participate in the clinical trial which will enroll participants admitted in their hospitals.” According to the ICMR, the intervention arm of the trial will include baricitinib and the control arm will receive local standard of care. The trial will be initiated only after obtaining requisite regulatory and ethics approvals. “Institutions which are interested to collaborate with ICMR on undertaking this trial may express their interest by providing the details,” it said.
Informed consent has to be obtained from each patient before enrolment into the study. The protocol of the study describes a randomised trial among patients hospitalised for COVID-19.
All eligible patients are randomly allocated between several treatment arms, each to be given in addition to the usual standard of care in the participating hospital. At the Indian sites, all participants aged 18 years or above will be allocated to baricitinib vs. no additional treatment. The interim trial results will be monitored by an independent Data Monitoring Committee.