The Indian Council of Medical Research (ICMR) has invited Expression of Interest for providing clinical trials liability insurance for SOLIDARITY PLUS trial.
ICMR through ICMR-National AIDS Research Institute, Pune is coordinating a trial, titled “An international randomized trial of additional treatments for Covid-19 in hospitalized patients who are all receiving the local standard of care SOLIDARITY TRIAL PLUS” or World Health Organization (WHO)-India (ICMR) SOLIDARITY trial plus”, with at least 15 participating trial site.
In this study, adults (age =18 years) recently hospitalized, or already in hospital, with definite moderate or server Covid-19 and, in the view of the responsible doctor, no contra-indication to any of the study drugs and naïve to study drugs will be randomized to ‘Local standard of care’ alone (excluding study drugs) OR ‘Local standard of care’ plus only one of IV Infliximab as a single IV infusion or Imatinib given once a day for 14 days. The primary outcome is all-cause mortality, by severity of disease at the time of randomization.
This being adaptive protocol new drugs may be added to the trial or discontinued based on findings from interim analysis and recommendations of the Data and Safety Monitoring Board (DSMB).
The trial plans to recruit up to 750 patients meeting the inclusion and exclusion criteria set for the study, across at least 15 trial sites across India till completion of recruitment and follow up.
Clinical trial insurance is for Professional Indemnification for 250 investigators physicians and nurses and Compensation for ‘Trial related injuries’ for study participants as per ‘New Drugs and Clinical Trials Rules, 2019, [G.S.R. 227(E)] dated 19 March 2019’ and medical management for adverse events related to study drugs and not natural disease progression.
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