#Thread on clinical trials of #Itolizumab - 20 patients received the drug, another 10 patients (three died) received supportive care, four doses were given, 32 patients were randomized, two patients discontinued. says Dr Sandeep Athalye @Bioconlimited
Predominantly male participation with comorbidities like diabetes, thyroid and blood pressure issues. All 20 patients who were given the drug died. In the arm which did not receive the drug, 3 patients died and 2 needed invasive ventilation before they died. #Itolizumab
Key markers for inflammation IL 6 aand TNF alpha came down in those who received the drug. Serum Ferritin levels also came down. Even D Dimer markers which indicate clotting or coagulopathy #Itolizumab
Dr Rosemary D'Souza who heads critical care in #Nair hospital in #Mumbai says initial use of the drug #Itolizumab are encouraging - trick is to give it before cytokine storm starts. Before patient starts getting breathless. Or oxygen level starts dropping.
In Solapur, no lab facilities for measuring IL6 levels, testing is done in #Mumbai #Pune - Dr Vishal Gore says they gave #Itolizumab to in over 20 patients since past 20-25 days.
Can @Bioconlimited clarify if 20 were given drug under clinical trials, how were the addl 150 persons meted out the drug - when did @CDSCO_INDIA_INF give permission for "off label" use even ass clinical trial results were awaited #Itolizumab @PrabhaRaghavan @AnooBhu @LeroyLeo7
@CDSCO_INDIA_INF has given nod for Restricted Emergency Approval press release on July 11 - it seems this release is post dated as this restricted use was going on in 150 patients in multiple hospitals since 25 days @AnooBhu @LeroyLeo7 @PrabhaRaghavan @Bioconlimited @kiranshaw 
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