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SHA222 can you please give me a steer what section the link you mention is? I'm trying to see where you are pulling the data from
In my experience trial protocols are static documents that are written prior to commencement and change little during the trial unless amendments happen via the original ethics committee. It would not be a place to record trial progress. I hope I'm wrong. Thanks for any steer you can give
like him or loathe him, he's always interesting
Cummings
"In spring 2020 you had a situation where the Department for Health was just a smoking ruin in terms of procurement and PPE and all of that, you had serious problems with the funding bureaucracy for therapeutics on Covid."
He said the government's chief scientific adviser, Sir Patrick Vallance had advised Number 10 that the vaccine rollout should not be run out of the Department for Health and that a separate task force should be created.
"It's not coincidental that the vaccine programme worked the way it did. It's not coincidental that to do that we had to take it out of the Department of Health," he added.
Agreed 85% at p 0.002 is solid proof from a proper P3 RCT.
Canât see infusions taking off at scale in a pandemic though. Thatâs why one of their ongoing trials is comparing intramuscular injections with infusions. More realistic treatment if it still works, though still not possible by telemedicine, as our HT shows we are
https://covdb.stanford.edu/page/covid-review/#interferons
Although down the running order, interferons get a good write up and sng018 mentioned
Top lass Helen! I had been singularly unable to find it. Shows the huge body of work that has been done to get to the point of a successful inclusion in ACTIV2
https://video.lefigaro.fr/figaro/video/interferons-anticorps-monoclonaux-olivier-veran-fait-le-point-sur-les-traitements-contre-le-covid-19/
The original Le Figaro video from the press conference for those confident in French
Thanks for the correction/clarification PMJH. Good news indeed then. SPRINTER=SG018
Did we know SNG001 was to be made in Alsace, ,or was he referring to one of the MABs?
It may be FP-1201-lyo ?
Also known as Traumakine. Made by Faron Pharmaceuticals, based in Finland.
It is a type of interferon Beta 1A but I think it's IV use. Certainly a hospital in Alsace has been a centre in previous Traumakine studies but I don't think it's made there from what I can find. Traumakine is marketed for ARDS (Acute Respiratory Distress Syndrome), which is the disease process that causes many of the fatalities in COVID.
But as the future holds that many patients who have COVID will have been vaccinated, I fear the company has done the right thing including cases after vaccination. It is rare for such to need admission to hospital and need oxygen, both of which are required inclusion criteria to the P3 trial. So most will not have been vaccinated at enrolment.
Very important point MrDing. The answer is they are not excluded from the trial. The following are the SG018 exclusion criteria
1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay e.g. RT-PCR test.
2. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care.
3. Previous SARS-CoV-2 infection confirmed by a validated molecular assay e.g. RT-PCR test.
4. Any condition, including findings in the patientâs medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study
or that could interfere with the study objectives, conduct or evaluation.
5. Participation in previous clinical trials of SNG001.
6. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry
into this study or containing biologicals within 3 months prior to entry into this study.
7. Inability to use a nebuliser with a mouthpiece.
8. Inability to comply with the requirements for storage conditions of study medication in the home setting.
9. History of hypersensitivity to natural or recombinant IFN-Ă or to any of the excipients in the drug preparation.
10. Females who are breast-feeding, lactating, pregnant or intending to become pregnant
Allez les bleus
And Southampton
https://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Research/COVID-19/COVID-19-studies.aspx
https://twitter.com/dr_d_dosanjh/status/1354805472226725890
Birmingham recruiting
Enrico, I'm not that brave!
"Our product is a potentially effective treatment as it is a virus agnostic and, we believe, strain agnostic antiviral, which is easy to use in the hospital or home setting."
My new favourite word and home screen message!!
I reckon the day the UK home trial RNS arrives, assuming it beats ACTIV2, on 15th March. Itâll feel like my birthday!
Ok, Friday evening relaxation after a fine week!
What date do you predict we get to first ÂŁBn cap??
Love that text Tim, thanks
Itâs a patient reported questionnaire. Used to be used mainly in COPD.
âThe BCSS is a sum of responses to three questions rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms).â
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5131613/
Thatâs the validation study