I am not going to bang on about this but we often submit screening protocols for subsequent studies because they are non-interventional, involve no risk to the subject and enable screening activities to start prior to approval of the main studies. In this case the characterisation study is the first study and will be a distinct and separate protocol from the screening one. The RNS in Feb informed us that the characterisation study had received Ethics approval, it did not state that they had received MHRA approval, which I believe has not yet occurred. The proof of the pudding is that the characterisation study is not registered in Clintrials.gov and this has to be done prior to starting the study, irrespective of OO issuing an RNS or not. The idea of them wanting to keep the study under wraps is a bizarre one, given the media coverage to date around this collaboration. Anyway, ADYOR!
Hi Ivy, as you will see from Clitrials.gov, the characterisation study is not registered, only the screening protocol and this does refer to the fact that the 'screened subjects' will potentially be included in the characterisation study when it is approved. So no subjects have been recruited to the actual study, this is just 'screening'. As I am sure you will agree it would be very odd to put out an RNS confirming ethics approval and then not put out an RNS confirming MHRA approval of a 'first in type' study of such importance. So just wondering why this is taking so long???
Just wondering why the Covid 19 characterisation study has still not received regulatory approval? Ethics approval was gained over a month ago and the screening protocol was posted on Clintrials.gov on 5th February. No real mention from CF on this either. Any thoughts?
Finally topped up prior to the weekend - my waiting for the afternoon dip really didn't pay off!! However, its really good to see the SP gaining the momentum we have been waiting for. Chinese buying!!!???
DG - good question! I am wondering if this is why the MHRA approval of the challenge study has been 'delayed'. I actually sent an email to Hvivo a couple of weeks ago asking about the impact of the variants on the development of the challenge study but have yet to receive a reply. In my view the challenge agent would be one strain of the Covid-19 virus and that they would have to produce new challenge agents if the variants have mutated to a point where a given vaccine would not be effective. In my view the development of the variants has really made the CHIM approach much more 'challenging' ;). ofcourse ADYOR.
RE: I’d say we are in the process of being14 Jan 2021 15:21
My only other thought was around the potential impact of the 'new' Covid variants on the viability and validity of the challenge studies ie. is the Covid challenge agent representative of all strains? Perhaps that has caused some wheel spin with the government funded initiative, Hvivo and thus OO.
RE: Starting to get a bit worried11 Jan 2021 12:13
Oasis - I would be extremely surprised if there was a 'bonus' linked to the clinical trial outcome as that would be totally unethical!! I also think that confirmation of MHRA approval for the Covid CHIM study would be extremely impactful news!!
Rosco - I do think we will hear about the challenge study when approved. For one it will be registered on Clintrials.gov for all to see and secondly they will be advertising for healthy vols to participate - so impossible to keep out of the 'news'.
Also, we and the market already knew the Prep news released in the RNS today - remember the in depth discussions we had about it last week?? So the RNS 'old news' was never going to have a major impact IMHO.