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Correction - only asymptomatic do not require a follow up PCR test.
If you're interested in learning more about the design of the ACTIV-2 trial this is one to watch. It's 54 min long.
'Design Considerations in a COVID-19 Platform Trial -- Experience from the ACTIV-2 Trial'
https://www.youtube.com/watch?v=dSTE_-UuZI4
On September 17, 2021, the 5th Annual Boston Pharmaceutical Symposium hosted its 3rd webinar of the Symposium. Dr. Michael Hughes, Director, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health gave the talk.
But, you also have to bear in mind that cases in London are basically flat when you compare the past seven days vs the prior seven days. This would've been incorporated into their decision making, rightly so.
This is to be expected as London has the lowest vaccination rate in England. 14 Boroughs have a vaccination rate of between 50% - 59% and further 13 have between 60% - 69% based on two doses. That's out of 32 boroughs.
The-Lockie - if you refer to the protocol as per the below link you’ll notice there are two Primary Outcome Measures and sixteen Secondary Outcome Measures.
Top line results cover the most important measures and so would definitely include both Primary Outcome Measures and most probably (only) the first three Secondary Outcome Measures. It is of course possible that the company may include other Secondary Outcome Measures which were fully measurable during the first 35 day period. Additionally they may also include stats on things like demographics for example.
https://clinicaltrials.gov/ct2/show/NCT04732949?term=Sg018&draw=2&rank=1
Those dates refer to the full data set including 90 day observations. Top line results are basically expected any day now. Could be tomorrow, could be in a week’s time. But, probably prior to mid Jan.
This is one reason why it is important to produce sound quality clinical data - we don't want to be the subject of such an article/study. Needless to say commercialisation would suffer from poor quality data.
'High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine.'
'The supporting evidence was stronger for drugs and vaccines, with seven out of the 10 EUAs supported by randomized clinical trials.'
https://www.fdanews.com/articles/205954-most-covid-19-related-euas-lack-strong-supporting-evidence-jama-article-says
JAMA journal
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2787205?resultClick=1
Bloomberg article published today ‘Coronavirus Can Persist for Months After Traversing Entire Body’
‘The coronavirus that causes Covid-19, SARS-CoV-2, can spread within days from the airways to the heart, brain and almost every organ system in the body, where it may persist for months, a study found.
In what they describe as the most comprehensive analysis to date of the virus’s distribution and persistence in the body and brain, scientists at the U.S. National Institutes of Health said they found the pathogen is capable of replicating in human cells well beyond the respiratory tract.’
Bloomberg article
https://archive.md/93PWb
Study under review for publication
https://assets.researchsquare.com/files/rs-1139035/v1_covered.pdf?c=1640020576
*a bully. Not ‘the’
We’ve not had substantial news since 20 Jul 2020 and so you can’t really expect the world to be super excited. By substantial news I mean ‘positive trial results’. Everything in between is just progress, but nothing definitive.
That’s reality and reminds me of the quote ‘The truth is the bully we all pretend to like’. Great book btw - Shantaram.
Note the following corrections:
1) It’s a ‘79% lower risk of developing severe disease’ compared to placebo’ and not ‘deaths’.
2) The above refers to the Phase II ‘hospital‘ trial and not Phase II trial in general as there’s a ‘home’ leg too.
3) The Phase III trial, SG018, is not a UK/Europe trial, but a world wide trial. The same applies to ACTIV-2 or so is the belief in that it would not just be a USA based trial.
Me when I saw this evening’s chatter on this BB …
https://makeagif.com/amp/XiUk-P
Not the same company. The ‘s’ in ‘Nominees’ differentiate between the two Aurora companies.
The best way to understand the trend is to look at 'cases by specimen date' as that represents the day the test was taken. But, you need to look at the data up to and including the fifth last day. So for today they have reported cases up to 21 Dec, however for a complete picture you should look at cases up to and including 17 Dec.
The data suggests that England may have peaked on 15 Dec, but that's due to London reaching a potential peak on that day. As soon as any of the other regions take off, in the same way London did, then of course England's peak is still to be reached. All early days.
This number is misleading and technically incorrect. Cases reported on Wednesdays include tests processed on a delayed basis due to the weekend so Wednesdays' cases are basically a 'true up'. The true number for today is probably around 90k, if not lower. For example London's reported cases for today include 6k from the weekend and prior to that.
Matml74 - I guess it’s not a bad thing going over the target whether it was deliberate or accidental due to delayed reporting or strong recruitment over the last days. It could potentially be a ‘blessing’ if some participants have withdrawn from the trial.
Relax :-)
Topline results (i.e. primary endpoints and key secondary endpoints) will be released early 2022. So that should be early Jan. If Father Christmas feels sober enough to deliver delayed presents and most importantly does not get stuck in the chimney results could even land before then, but don’t get your hopes up as he stuffed his face on mince pies.
The trial end date of 11 Feb 2022 is not a push back. Most of the secondary end points are measured over 90 days and this date reflects the gathering of such data.
The publish date of 01 Mar 2022 would be when they release data relating to ALL endpoints (primary and secondary) - in my view.
The following changes of note were made today to the ISRCTN version of the protocol
1) Total final number of participants: 623 (target was 610)
2) Overall end date changed to: 11 Feb 2021 (reflecting 90 day follow up)
https://www.isrctn.com/ISRCTN85436698
There won't be vague data, unless SNG001 basically ends up being a flop.
SG018 focused on patients requiring oxygen which is already a subset of the type of patients (i.e. at higher risk) recruited for SG016 hospital. This approach was supported by data from the combined analysis of SG016 hospital and home trials. And, I believe it was also indirectly supported by data from ACTIV-2 based on the language used in the latest ACTIV-2 protocol. Therefore, the chances of having to 'manoeuvre the numbers' due to vague data are very slim.
The topline readout does not just focus on deaths. It will cover the following measures (at least).
1) Time to hospital discharge
2) Time to recovery
3) Progression to severe disease or death
4) Progression to intubation or death
5) Death within the first 35 days of first dose
Bloomberg published an article explaining why SA seems to have mild cases.
‘Leading scientists cautioned that the level of immunity against the coronavirus among South Africa’s population due to earlier infections may be masking the severity of illness caused by the omicron variant.
A recent seroprevalence survey in Gauteng, the South African province where the omicron variant was first identified, showed that 72% of the population had a previous infection with the coronavirus, said Shabir Madhi, a vaccinologist at the University of the Witwatersrand. That compares with about 20% when the beta variant emerged a year ago, said Madhi, who led trials of both AstraZeneca Plc’s and Novavax Inc.’s shots in South Africa.
https://archive.md/TGpu2