“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 stated.
“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 embrace baricitinib and the management arm will obtain native normal of care. The trial might be initiated solely after acquiring 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 stated.
Informed consent has to be obtained from every affected person earlier than enrolment into the examine.
The protocol of the examine describes a randomised trial amongst sufferers hospitalised for COVID-19. All eligible sufferers are randomly allotted between a number of remedy arms, every to be given as well as to the same old normal of care within the taking part hospital.
At the Indian websites, all individuals aged 18 years or above might be allotted to baricitinib vs. no extra remedy. The interim trial outcomes might be monitored by an impartial Data Monitoring Committee.