DGCI clears Biocon's anti-CD-6 inhibitor for Moderate to Severe COVID Patients for Restricted Emergency Use. https://www.news18.com/news/india/dcgi-approves-psoriasis-injection-itolizumab-for-restricted-emergency-use-to-treat-covid-19-patients-2710927.html

Was granted Clearance on basis of multicentre small phase-2 trial (20 Patients in Itolizumab arm and 10 in Placebo). Small numbers
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42878&EncHid=&userName=Itolizumab

No Top line results on any benefits in Primary or secondary end points though akin to Favipravir.
. Cost a bit cheaper than Tocilizumab which is being used in Cytokine Storm phase of COVID as well n black marketed. However wider data lacking.

This PIB press release , curiously (can't be accessed now). Shows some benefits in secondary end point. No apparent benefits in Primary Outcome(possible due to underpowered nature of this feasibility trial).
https://twitter.com/PIB_India/status/1281846860743716865?s=20

So Dr. Shaw shares Trial met Primary end point and no deaths in Itolizumab arm (0/20)
I did some calculations.Thus in Placebo arm at least (3 or more out of 10 must have died to meet statistical significance).Nice
Wd be interested in Standard Of Care used https://twitter.com/kiranshaw/status/1282161381265965056?s=20

These details along with severity of Patients and treatment used for supportive care are very important for adoption of promising evidence by Medical community treating COVID.

Some other details emerging from this discussion on India today on Standard of care used in Thai trail
1) They used steroids in most patients.
2) They didn't use Remedesivir as it wasn't available when trial started

3) They used drug in Pre-Ventilation Stage . No one in Itolizumab arm(n=21) died or even progressed to Mechanical Ventilation. Sounds Too good. I am happy and Hopeful but a bit skeptical as well. Would like to look at Time to Recovery Curves and other details n try.

Dr. Joshi(PI) and Dr. thacker give nice overview on how Itolizumab fits in therapy staircase. However Dr. Joshi makes an incorrect (IMO) assertion,Steroids improve mortality in Ventilated Patients only. In RECOVERY trial , dexamethasone showed benefit in Oxygen subgrp also

In fact
Remedesivir improves mortality in Oxygen Subgroup and not in Critically ill (NIH-ACTT1 trial),
While Dexamethasone improves mortality in both severe (needing oxygen) and Ventilated (Critically ill) Patients.

Dr. Shaw tells many people are using it off-label and it has been given to 100 Patients, in particular a doctor from Sholapur who has used it widely and successfully in his Patients.
Dr. Thacker said he needed only 1 dose(~100 mg ,cost around 32000) for his Patients for Recovery.

Dr. Joshi tells us about his experience with Drug. Itolizumab should be used as slow infusion over 6 hours to prevent risk of adverse effects while infusion. https://twitter.com/AskDrShashank/status/1281846634804965376?s=20

Biocon Formally Confirms above inferences:Both Primary (mortality) and secondary end point met(Biomarker) with no need of Mechanical Ventilation and no mortality in Itolizumab group in this trial.

https://www.biocon.com/biocon_press_release_20200711.asp