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ICMR and University of Oxford to conduct India-UK RECOVERY trial of baricitinib for Covid-19

Neethikrishna, Mumbai
Wednesday, July 14, 2021, 08:00 Hrs  [IST]

The Indian Council of Medical Research (ICMR) along with University of Oxford is proposing to conduct a multi-centre, adaptive platform trial in Covid-19 patients, titled ‘India-UK RECOVERY (Randomised Evaluation of Covid-19 Therapy) trial.

The intervention arm of the trial will include baricitinib. The control arm will receive local standard of care. The trial will be initiated only after obtaining requisite regulatory and ethics approvals.

The 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.

The interim trial results will be monitored by an independent Data Monitoring Committee (DMC). The most important task for the DMC will be to assess whether the randomised comparisons in the study have provided evidence on mortality that is strong enough (with a range of uncertainty around the results that is narrow enough) to affect national and global treatment strategies. In such a circumstance, the DMC will inform the Trial Steering Committee who will make the results available to the public and amend the trial arms accordingly. Regardless, follow-up will continue for all randomised participants, including those previously assigned to trial arms that are modified or ceased. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.

The main outcomes will be death, discharge, need for ventilation and need for renal replacement therapy. For the main analyses, follow-up will be censored at 28 days after randomisation. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases where available.

The larger the number randomised the more accurate the results will be, but the numbers that can be randomised will depend critically on how large the epidemic becomes.

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. To begin with, at the Indian sites, all participants aged 18 years or older will be allocated (1:1) to baricitinib vs. no additional treatment.

The last date for submitting the application is July 20, 2021.


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