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Thanks Peter, that was my opinion of it, fairly inconclusive, I read another piece similar the other day talking about the ACE2 receptors and asked if interferon beta could actually cause more damage but they said its likely to depend on what point it's delivered. Seems to me there's a strong indication for prophylactic use.
Always important to share research good or bad, allows us to go into this with our eyes wide open. It's up to each individual whether they choose to act on it...
Mac57 key bit in there it states
'Once drug manufacturers have received a scientific opinion from the Medicines and Healthcare products Regulatory Agency, doctors will work with patients to prescribe the drugs when appropriate.
In return, the companies will be able to gain experience of their medicines being used in the NHS and work closely with regulators to look at the value of the drugs, gaining guidance and advice much earlier in the regulatory process.
As a result, the process of patient access will be speeded up and new drugs could be made available to patients months or sometimes years before the treatment is licensed.'
From what I've read it looks like FDA are much more open to 'adaptive licensing' and moving to mass use of drugs without completing phase 3 trials. I think Trump would jump on this, considering he's proposing injecting domestos into our bodies....
On balance I think with all the research they've put in for copd and asthma, it shouldn't be a problem it's only phase 2 trial. IMO
Even though it's a small pilot of 100 patients I'm confident they know their product well enough to choose which patients are going to get the best results and get a statistically significant result.
Hold!!!
Impaired type I interferon activity and exacerbated inflammatory responses in severe Covid-19 patients
ww.medrxiv.org/content/10.1101/2020.04.19.20068015v1
Further evidence interferon type 1 lacking in covid patients.
Just doing a bit of research on this, it's not an approved drug yet much like sng001 undergoing phase two trials so in a similar position in terms of development. Hard to give an opinion on mode of action as that's not my field but in terms of timing, they don't start recruiting until May and need 300 patients so we will know before they finish whether sng001 has had positive results. I do worry with sng001 only being phase 2 and not phase 3 we could hit a regulatory barrier. It's in the back of my mind...still going to hold until results day mind!
I think the post and lancet article earlier from Jack Allis points to this treatment working best as a pretreatment or at very very early stages of infection. That piece from sky just posted last month also talks about uninfected lung tissue. My feeling is that it'll be predominantly preventative at home treatment, so mass produced for vulnerable and shielded patients. My 2 cents...
I'm a dentist which is one of the highest risk professions due to the generation of aerosols and close proximity to the airway, I imagine every dentist in the world will want to test every single patient before they take a drill to them. That's billions of tests worldwide.
I'm not convinced the May 2021 is a typo, the SG016 trial on the EU clinical trial register states 400 patients to take part, 200 from member state and 200 from elsewhere. What we are doing currently is the 'pilot phase' of 100 patients as detailed here on synairgens website:
'Synairgen’s Phase II trial in COVID-19 patients, called SG016 (EudraCT: 2020-001023-14), is a double-blind, placebo-controlled trial. Initially, the pilot phase of the study involving 100 COVID-19 patients, is taking place across a number of NHS trusts. It has been adopted by the NIHR Respiratory Translational Research Collaboration which is comprised of leading centres in respiratory medicine in the UK whose internationally recognised experts are working together to accelerate development and discovery for COVID-19. A successful outcome from the pilot phase will inform onwards progression of SNG001 in COVID-19 patients. The trial, labelled by the NIHR as an Urgent Public Health study, commenced at the end of March.'
I don't know what the significance of onward progression means? Is that further trials or is rolling out for public use. It doesn't have an end date on the SG016 piece on the clinical register, it just says ongoing.
Does anybody know the significance of a phase 2 trial? I know we are in unprecedented times, but in normal times can you go straight from phase 2 to public use or do you have to do phase 3?
I'm heavily invested here but want to get as much information as possible and make sure there's no obvious regulatory hurdles we might be overlooking.
That is a more accurate and formal piece compared to what I read so you are probably right. If that is the case then there is a very strong chance the Prof was talking sng001. He was extremely bullish at the end of the interview about the trial. Fingers crossed. How are you posting the link?
Looks like sng001 has its own 'study' now, not sure if this is since it was made urgent
https://www.leicestersresearch.nhs.uk/about-us-2/covid-19-and-clinical-research/covid-19-trials/
Confirms Leicester are trialling it.
The guy did say he was in a bad way and then his lungs just started to work. I'm reading massively between the lines, but forever hopeful. I've looked at the Twitter hashtag priorityCOVIDresearch which seems to be what some of the hospitals are using and if you look there are no mentions really of any other medication other than hashtags of synairgen or sng001 so despite it not being in the national news mainstream media, hospital Twitter accounts are highlighting it more than other trials.