Coronavirus (2021) thread

[splinter]

Study so successful it's been stopped early! - Big breakthrough here on the anti-viral side from Glaxo - Now we have first class preventative vaccines being administered and finally a very promising antiviral to help all those who haven't had the vaccine yet and get admitted to hospital - the net is closing on you covid!


A new antibody drug “reduces hospital admission or death from Covid-19 by 85%”, the pharmaceutical giant GlaxoSmithKline (GSK) has announced.

PA reports:

Fantastic news..thank you science&scientists

 

[PannickAtTheDisco]

Study so successful it's been stopped early! - Big breakthrough here on the anti-viral side from Glaxo - Now we have first class preventative vaccines being administered and finally a very promising antiviral to help all those who haven't had the vaccine yet and get admitted to hospital - the net is closing on you covid!


A new antibody drug “reduces hospital admission or death from Covid-19 by 85%”, the pharmaceutical giant GlaxoSmithKline (GSK) has announced.

PA reports:

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

 

[Indaparkside]

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

Let’s march on capital hill

 

[Tim of the Oak]

Good to hear about the Glaxo results. It’s even better news for the Countries who have continually surprised the virus to give themselves breathing space until better medication is developed.

 

[AlgarveBlu]

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

We are in unprecedented times and need to take calculated risks both with the vaccines and anti virals (10 year is vaccine average from lab to arm). Every passing month that we remain in this purgatory the number of indirect consequences of covid on mental health, undetected/treated diseases, childrens education and peoples livelihoods catches up with the direct fatality rate from deaths.

I also suspect this treatment will also have a positive impact on the reduction and severity of long covid for those admitted to hospital.

 

[roubaixtuesday]

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

First, a disclaimer: I know nothing about this specific trial, so what follows is general.

There are a couple of mechanisms for closing trials early.

An independent datamonitoring committee normally oversees this.

They will see safety reports coming in and act to stop a trial if safety data shows unexpectedly poor results. That can be permanent or temporary whilst investigated. You may recall this happening for a couple of the vaccine trials.

Secondly, an interim readout may be taken. This has to be specified in advance. The trial will be designed to take, say 200 patients, and an assumption on how effective the drug is dictates that size. For our 200 patient study, let's say that's designed to reliably show a 60:40 ratio of outcome in favour of the drug over the placebo. So we get 60 of 100 pts improve on drug, 40 of 100 on placebo; that shows the drug is effective, and the numbers are large enough we can be sure is not just a random effect.

But what if the drug is far more effective than placebo? Maybe 90:10 rather than 60:40? If the investigators think that's likely they will specify an interim analysis, which means results will be available much earlier. Lets' do that for just 40 pts. We'd see roughly 18 of 20 improve on the drug, but just 2 of 20 on placebo. Those numbers are obviously meaningful and the drug is clearly effective.

Now, it's not just unnecessary to continue the trial, it's unethical, as we're giving patients a useless placebo when we know we can save their lives with the drug.

Hope that makes sense.

 

[ell]

Denmark has suspended use of the AZ/Ox jab it seems whilst they investigate. Blood clots.

 

[west didsblue]

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

According to GSK:
"Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalisation or death."
So it's not the companies developing it choosing to do that, it's an independent monitor because they think GSK and Vir should push ahead with emergency use authorisation as soon as possible.

 

[PannickAtTheDisco]

According to GSK:
"Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalisation or death."
So it's not the companies developing it choosing to do that, it's an independent monitor because they think GSK and Vir should push ahead with emergency use authorisation as soon as possible.

ok, thank you for the clarification. As with the vaccines I will trust that the systems in place are robust enough.

 

[PannickAtTheDisco]

First, a disclaimer: I know nothing about this specific trial, so what follows is general.

There are a couple of mechanisms for closing trials early.

An independent datamonitoring committee normally oversees this.

They will see safety reports coming in and act to stop a trial if safety data shows unexpectedly poor results. That can be permanent or temporary whilst investigated. You may recall this happening for a couple of the vaccine trials.

Secondly, an interim readout may be taken. This has to be specified in advance. The trial will be designed to take, say 200 patients, and an assumption on how effective the drug is dictates that size. For our 200 patient study, let's say that's designed to reliably show a 60:40 ratio of outcome in favour of the drug over the placebo. So we get 60 of 100 pts improve on drug, 40 of 100 on placebo; that shows the drug is effective, and the numbers are large enough we can be sure is not just a random effect.

But what if the drug is far more effective than placebo? Maybe 90:10 rather than 60:40? If the investigators think that's likely they will specify an interim analysis, which means results will be available much earlier. Lets' do that for just 40 pts. We'd see roughly 18 of 20 improve on the drug, but just 2 of 20 on placebo. Those numbers are obviously meaningful and the drug is clearly effective.

Now, it's not just unnecessary to continue the trial, it's unethical, as we're giving patients a useless placebo when we know we can save their lives with the drug.

Hope that makes sense.

It does, so thank you. My cautiousness would be "great, it clearly seems to work but what are the effects after x months that we can't see unless we keep trials running". Maybe it's not an issue but given my age bracket I worry about the longer term for these things.

 

[MillionMilesAway]

forgive me, to me that sounds like Trump stopping vote counting early because he was winning. Surely if something is working you keep testing it to ensure there are no pitfalls down the road you haven't encountered yet?

It is a bit odd on the face of it - what they've actually done is stop enrolling new people in the trial (which is 583 people), and it's at the recommendation of a monitoring committee, it seems.

Vir Biotechnology and GSK Announce VIR-7831 Reduces Hospitalization and Risk of Death in Early Treatment of Adults with COVID-19

– Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalization or death – – Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries – Vir Biotechnology, Inc. (Nasdaq...

investors.vir.bio

Should be noted that it has no effect on the very sick., but around 85% (as I read it) for mild-medium

 

[roubaixtuesday]

It does, so thank you. My cautiousness would be "great, it clearly seems to work but what are the effects after x months that we can't see unless we keep trials running". Maybe it's not an issue but given my age bracket I worry about the longer term for these things.

Your caution is perfectly reasonable.

Phase 3 trials are normally looking at two things, benefit(efficacy) and risk(safety).

All drugs, not just this one, are approved on the balance of the two.

So, for instance, a new headache pill has to prove its extremely safe, as the benefit can only ever be fairly low. A new cancer drug, on the other side, can be approved with all sorts of unpleasant side effects if it cures a fatal cancer.

This population is at extremely high risk - the chances of dying of COVID are about 10% for older people. So not having a huge safety database is reasonable, given the benefit.

Normally on approval the regulator will mandate further in use studies to gather more data on safety and efficacy if initially approved on a small study or interim data.

 

[Marvin]

you said that without saying The word variant but still kind of said it. Well done.

Almost all the virus in the UK is variant virus. I believe Covid-19 is on its way out but the risk of it being prolonged and developing a nasty tail is almost entirely due to variants so this is what I follow. I take it as a given that the vaccine will wipe out the UK variant so the only thing that stands in the way of normality is its evolution, and that is directly linked to places like Brazil where the epidemic is still out of control.

In brief: It's the Invariants stupid!

 

[True_Blue69]

I look for information pertinent to the outcome of the epidemic. 6 months ago it was vaccine development, now the vaccines are deployed I want to see what is happening with the virus because the vaccines were designed to neutralise the original strains. These are the developments that shape the course of this epidemic.

Which is fine and no doubt will present useful info. But your post didn’t mention that only 4% of Brazil have had the vaccine, so was misleading at best. At least add the proper context to what you post as on face value that appeared as though the virus is out of control despite the vaccine, which is not the case and therefore not relevant to the UK at all.

 

[Quad]

Almost all the virus in the UK is variant virus. I believe Covid-19 is on its way out but the risk of it being prolonged and developing a nasty tail is almost entirely due to variants so this is what I follow. I take it as a given that the vaccine will wipe out the UK variant so the only thing that stands in the way of normality is its evolution, and that is directly linked to places like Brazil where the epidemic is still out of control.

In brief: It's the Invariants stupid!

This is why we should maybe keep our borders closed till next year

 

[west didsblue]

Which is fine and no doubt will present useful info. But your post didn’t mention that only 4% of Brazil have had the vaccine, so was misleading at best. At least add the proper context to what you post as on face value that appeared as though the virus is out of control despite the vaccine, which is not the case and therefore not relevant to the UK at all.

He said the virus was out of control in Brazil which it is. Most people know that vaccine rollout worldwide is a fraction of what's happened here so it doesn't really need to be said. What's your problem?

 

[west didsblue]

Worldwide vaccine tracker

https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html

 

[grunge]

Almost all the virus in the UK is variant virus. I believe Covid-19 is on its way out but the risk of it being prolonged and developing a nasty tail is almost entirely due to variants so this is what I follow. I take it as a given that the vaccine will wipe out the UK variant so the only thing that stands in the way of normality is its evolution, and that is directly linked to places like Brazil where the epidemic is still out of control.

In brief: It's the Invariants stupid!

At this point its all new strains / variants. the original strain detected in Wuhan was wiped out in the Chinese lockdown early last year.

There is certainly a natural progression path this virus seems to be taking though with lots of similar mutations occuring in isolation.

 

[True_Blue69]

He said the virus was out of control in Brazil which it is. Most people know that vaccine rollout worldwide is a fraction of what's happened here so it doesn't really need to be said. What's your problem?

That it was a pointless post. Would you say the same if I posted ‘the virus is under control in NZ’ and nothing else. Pointless and deliberately negative.

 

[Healdplace]

Wales data:

12 deaths - was 13 last week

195 cases - was 267 last week

1.6% positivity - was 2.3% last week (in other words more tests find fewer cases).

Weekly Pop score 43 - up from 42 yesterday - was 53 last week

(There was a small rise in cases yesterday hence the first rise in ages here. But tomorrow will now fall again by the looks of it given todays case and positivity drop)