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Matterhorn, it can only be done at the prearranged “peeks” into the trial by the Data Monitoring Committee. I have never had seen the full trial protocol to know the plan. The protocol is a big document, maybe 30-100 pages for a modern RCT, and will include the plan for the DMC. All only my best guess obviously
Peelweight - question re your first caveat. Does the detailed trial protocol need to explicitly state early termination as a possible recommendation when it’s unethical to continue due to proven efficacy or is it standard across trials?
Hi everyone, thanks for this thread and to Bosi for finding this info. To be clear this is no third party site. This is THE ethics committee that gave ethical approval for the multinational trial (Riverside). And we are looking at a recent update 20/7/21.
The dates do make sense if you only look at the primary and secondary outcomes within the text in this ethics approval. The longest secondary outcome is 35 days. It's 35 days between 1/10/21 and 5/11/21.
It is true that 90day data is being sought and the US site lists that. However, I believe this is the latest and most likely to be accurate estimate of last patient recruited -1/10/21. I'm a little heartbroken to see we will struggle to EUA prior to winter in N Hemisphere.
There are two caveats that may help
1) the data monitoring committee may call a premature end to recruitment if it is unethical to continue as proven effective. This would stop recruitment early.
2) a country could EUA anytime they feel they have enough provisional data to take that step and would continue to monitor the data collection. This seems less likely to me
All will be revealed in due course. I’m neither frustrated or overly excited.
When Synairgen have something to tell us they will.
In the meantime, I’m just patiently awaiting news.
Doc
You make a very good point SG016 completed in 15 weeks .I am getting very frustrated thinking that the treatment might not be available in the Autumn as this was going to be a chance to showcase the treatment against all circulating respiratory viruses .It seems now Autumn booster jabs will do the job .Also all this confusion on trial completion dates is frustrating and we desperately need an update at least on clarification on progress
First completion was for summer 2021, and only in the latest update he said H2 2021.. delays were inevitable..
I disagree with you both there,
In October 2020 during a published online proactive interview with RM and pre-fundraising, RM stated the company's 'Aim' was to complete the P3 Sprinter trial by MARCH 2021.
Then when the trial dates where published we found out estimated completion was September 2021
Then the official delay occurred stating estimated completion October 2021
Now other sources claim estimated completion November 2021
Matml74 - agree RM always stated H2, however that is no excuse for continually publishing incorrect dates. For example one set of dates suggest a top line read out in Q3, which we now know won’t happen, while another suggests Q4. That’s quite a difference.
I am just someone who values things being done right.
The trial will be completed and readout second half of 2021. That has been the position of the company all year. Nothing has changed.
I must admit that is causing me some head scratching too, Matterhorn. As a LTH I am constantly reassessing risk/reward against timescales that we are fed. To be fair to the company, this is in line with their issued info and interview comments but it does cause confusion potentially. I shall revert to company issued info I think and not place too much credence on 3rd party sites until it becomes more clear.
The dates don’t make sense. I find it frustrating that whoever is responsible for updating the protocols continue to put incorrect information out in the public domain despite informing them twice about it via Consilium.
You can’t have a recruitment end date of 01 Oct with a overall trial completion date of 05 Nov. There should be a 90 day gap between the two dates. 05 Nov could be the primary completion date, but what are we supposed to believe?
Defo been put back but not really surprised given how many counties are involved and the stresses many health services have been under.
Get it done before winter will be a good result. Covid unfortunately isn’t going anywhere if anything it will gradually unlock the vax code. Clever thing viruses.
Trek
End date: 05/11. Recruitment completed by 01/10 at the latest.
I saw the same re the last updated date being 20/7 but couldn't figure out what had changed. haven't SNG always said second half of 2021?
Came across this https://www.isrctn.com/ISRCTN85436698 with updated editorial notes at the bottom (changes made 20/07/21). These dates are not yet reflected on the NIH but appear to push into November 21. Very specific dates as opposed to the estimates on https://www.clinicaltrials.gov/ct2/show/NCT04732949