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Thx for that Joey - the ‘Conclusion’ section addressed my questions. Good to know.
Equally important to consider and take on board any limitations.
Scinv - thx.
Joey - nope I haven't which I've stated.
Belgium got added to the EU trial register overnight. According to this version of the protocol the Ethics Committee Opinion was only issued on 31 Mar whereas the version as per the Belgian clinical trial register stated a recruitment start date of 10 Mar. So I guess it's better to assume recruitment would not have started until April. Frustrating.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004743-83/BE
https://databankklinischeproeven.be/en?title=&medical_condition=&age_range=All&subject_type=All&eudract_number=2020-004743-83
Scinv - If you look at the below sentence where it says poorly induced AND once infection was established. This statement seems to suggest low IFN levels are part of the bigger problem being discussed in the study, hence the use of the word 'and'.
(I'm assuming so.) So with that in mind i.e. low induced IFN, would an IFN based treatment like SNG001 not still be effective to SOME extend to prevent further infection i.e. replication due to higher levels of IFN and a higher likelihood of downstream success even though there are all these other issues as discussed? I guess it's fair to say there's not a TOTAL breakdown of downstream functions.
Secondly, and I don't have access to the full article, but it states IFN type 1 and does not specify in the abridged version which type 1 IFN they're discussing. Would these findings affect all type 1 IFNs or potentially only alpha or beta for example?
'Type I IFNs and IFN-stimulated genes (ISGs) were poorly induced during SARS-CoV-2 infection and once infection was established, cells were highly resistant to ectopic induction of IFNs and ISGs.'
Poor sarcastic effort there Scinv. As someone who like sarcasm I demand a better effort and I know you can do better.
On the tin it may not sound as something of much value, but if you actually think about it you’ll realise it’s potentially significant. SG016HOME might be too small so that combined with an ‘earlier’ ACTIV-2 result, provided all is good, will be a ‘Yay!’ for your return on investment. The sooner results are available, again provided they’re good, the better for your investment which is why you’re invested.
The good bit is this extract from my post.
‘... we wouldn’t have been able to start with ACTIV-2 recruitment in Feb, potentially much later.’
US & France also granted priority status.
US: refer to 18 Dec RNS
France: https://solidarites-sante.gouv.fr/soins-et-maladies/maladies/maladies-infectieuses/coronavirus/professionnels-de-sante/recherche-sur-la-covid-19/etudes-cliniques-labellisees-priorite-nationale-de-recherche-sur-la-COVID-19
It dawned on me earlier that we may just count ourselves lucky with regards to ACTIV-2. Here’s why.
Synairgen is doing the ground work for future mass production through their manufacturing partners so they currently only request production to satisfy quantities required for trials.
The original SG018 protocol had a third arm which was subsequently dropped resulting in 300 fewer trial participants and excess SNG001 . We were informed of this on 18 Dec.
My thinking is that during their discussions with the US regulator, the FDA knowing there’s only limited quantities of SNG001 thought it would be better to conduct an ACTIV-2 phase II study instead of doing a phase III lower dose arm i.e. better use of trial resources and potentially an expectation that the likelihood of success would be higher than a lower dose arm.
The ACTIV-2 protocol dated 22 Dec stated that SNG001 will be available at a limited number of sites so this tells me the company was aware of ACTIV-2 inclusion by the time we received the phase III update four days earlier on 18 Dec.
Therefore, if it wasn’t for the third lower dose arm which eventually got dropped we wouldn’t have been able to start with ACTIV-2 recruitment in Feb, potentially much later. This also explains the ‘restricted number of sites’ comment in the ACTIV-2 protocol.
I might be wrong, but then again it makes sense.
Don’t give the BBC too much credit. The interview with Richard used for the phase III trial was the same as the one from 20 Jul 2020.
Oak - got to agree with Doc. Let's not throw around numbers if we can't substantiate it. Personally I'll ignore the quoted number and I'll say the following ...
The number you quoted is not impossible, however from 01 - 23 Feb it does require a recruitment rate which is about seven times higher than what both SG016 and Recovery have achieved. We suspect recruitment rates were just below 1% prior to Feb based on an interview with Prof Djukanovic.
miss_nosaj - here goes ...
SG016 hospital (phase II) - results released 20 Jul 2020.
SG016 home (phase II) - 120 participants. Results expected Q2 2021.
SG018 (phase III) - Recruiting. 610 participants in hospital setting in up to 16 countries. Top line results expected in summer 2021.
ACTIV-2 (phase II) - Recruiting. US based trial in the home setting. 220 participants.
Oak - those three alone recruited 81 patients? Wow! Can I ask how you know this? If that's the case it seems the UK might be aiming for the original target of 200 patients which would be great news.
Doc - Re Romania it could just be how their spreadsheet works in that, that particular section only lists the last week's approvals. But, not sure what to make of it really. Doubt it'll be a withdrawal of approval or an error.
Categorisation is based on official online documents published by each country’s health authority, unless otherwise stated, which raises the possibility that the actual trial status may have progressed from what is stated here.
1) RECRUITING
United Kingdom (estimated 135 – 200 px at 8 sites) *
United States *
Belgium
2) APPROVED
Spain (87px at 11 sites, 19 Mar)
Portugal (50px at 5 sites, 17 Mar)
Italy (41 px at 11 sites, 02 Apr)
France (06 Apr) *
Romania (06 Apr) *
3) PARTIAL APPROVAL
India (88px at 10 sites, 13 Apr) *
4) APPLICATION PENDING
Colombia
Argentina
Brazil
Israel
Mexico
Serbia
5) REMOVED
Germany *
* Notes:
- UK: Prof Wilkinson said there were 15 plus sites in the UK as at 21 Feb, although official records from 03 Mar list eight.
- US: Recruitment based on a tweet showing a screenshot of PharmaTex Research LLC’s recruitment brochure in Amarillo, Tx.
- India: Approval received from Regulator. Approval from five sites outstanding. Trial start date 04 Jun.
- Germany: Removed from list as per latest EU register update for Italy.
- Romania: Most up to date excel file does not contain SG018, but it might just be that the file only contain latest updates for some sections. Not sure.
Doc - I have. Will post a summary later.
Yes, that could be the case. Italy, Portugal & Spain have a combined planned total of 178. That leaves us 56 short of the the 234 target. Belgium & France’s planned numbers are unknown and so too Romania.
Italy approved SG018 trial.
Anticipated no. of sites: 11
Planned no. of participants: 41
Date of approval: 02 Apr 2021 (bloody late!)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004743-83/IT
Interestingly Germany has been dropped from the list of countries. Error or not ...?
DPC1825 - they’ll prob just say it progresses well.
The protocol does not get updated regularly and it’s done poorly to be frank. Prof Wilkinson said over 15 sites as at 21 Feb, yet the updated protocol from 03 Mar states eight sites. This kind of thing must not happen.
Nope
Re SG018 UK arm. Original protocol stated 200 patients. We don’t know whether this number has been amended down (or even up which I doubt).
At the end of Jan we had recruited about 40 according to Prof Djukanovic from his interview. Prof Wilkinson said we had 15 sites as at 21 Feb.
I’m not in front of my computer, but from memory predicted around 130 patients towards the end of March which was based on 10 sites. I think. Would need to check.
Oak - has anyone from Reddit any knowledge as to whether we’re still recruiting in the UK?
Schrow123 - re your first question I’d say yes. But, it may not be of any benefit to us if they require any or all findings from ACTIV-2 phase II. Should SG016HOME satisfy all their needs then we may benefit of course. Personally I’ll go for worst case scenario.
Re your second question. You’ve basically answered your question. Exactly that yes.