@AnooBhu has got me interested in looking at the trials registerd in #ctri (ctri.nic.in/Clinicaltrials…) Limiting it to Covid trials there are a total of 477 records. Many are observational studies so not really trials at all. Some are of homeopathic treatments.
Some are sponsored by pharma cos. Many are badly designed and unlikely to set the world alight. Some are downright mischievous. But let me comment on one that is downright naughty. It is Registry No CTRI/2020/06/025957 by Glenmark Pharmaceuticals Limited. This is a set up.
It covers 21 trial sites - mostly teaching hospitals, hopes to recruit a total sample of 158 patients hospitalized with mild-mod symptoms of pneumonia (SpO2 <93%) to be randomly allocated by computer to receive either
A) favipiravir, or
B) favipiravir + umifenovir.
Of course Glenmark manufactures Favipravir as FabiFlu. and it has already claimed that it is effective compared to a placebo on the basis of a trial in 150 patients across 7 sites. See prnewswire.com/in/news-releas…
Has it featured in the BMJ's live Networked Meta Analysis?
Not yet because it hasn't been published yet. But the press release claims:
What about the other arm of the trial. It is Favipiravir + Unifenovir. Now his latter drug, Umifenovir has been around for some time and the Govt's agncy, CDRI (Central Drugs Research Institute) and CSIR are doing a phase-3 trial of it. pharmaceutical-technology.com/news/indias-cd….
So here's my problem with this Trial No. CTRI/2020/06/025957 of Favi vs Favi +Umfenovir.
Where is the therapeutic equipoise that would justify such a comparison? And whichever way it goes, it would be a win-win situation for good old favipiravir.
The big objection is that there is no placebo group. What if Favipravir is effectively no better than placebo and the Umfenovir has some small effect that is masked by Favipiravir? How are we ever going to tease out all this mess?
The only benefit of this trial, whatever the results is that doctors in these 21 hospitals will get used to writing prescriptions for FabiFlu aka Favipiravir to all the 150 patients in the trial. This is marketing thinly disguised as a clinical trial.
I wager it will never get written up, never mind published in a half respectable journal. Since these are teaching hospitals, it might get into 1 or 2 MD dissertation, may be a conference poster once lockdown ends. But is it serious research? #Cornavirus must be laughing at us.
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