Gilead data suggests coronavirus patients are responding to treatment(statnews.com)
statnews.com
Gilead data suggests coronavirus patients are responding to treatment
https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/
28 comments
Why was it even allowed? Isn't there some requirement for a trial to be called Phase 3?
A Google search resulted in this:
The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug.
https://clinicaltrials.gov/ct2/show/NCT04292899
,,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)''
The title doesn't contain Efficacy :(
A better clinical trial (but with fewer participants) will be run in Norwegia, but we're supposed to get results only in August. I don't understand why we're losing so much time by not running studies all the time.
https://clinicaltrials.gov/ct2/show/NCT04321616?term=Remdesi...
A Google search resulted in this:
The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug.
https://clinicaltrials.gov/ct2/show/NCT04292899
,,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)''
The title doesn't contain Efficacy :(
A better clinical trial (but with fewer participants) will be run in Norwegia, but we're supposed to get results only in August. I don't understand why we're losing so much time by not running studies all the time.
https://clinicaltrials.gov/ct2/show/NCT04321616?term=Remdesi...
Norwegia aka Norway :)
"Because Indonesians come from Indonesia, and Russians come from Russia, Norwegians come from Norwegia." - Urban Dictionary
"Because Indonesians come from Indonesia, and Russians come from Russia, Norwegians come from Norwegia." - Urban Dictionary
Recently I learned that the demonym for San Marino is "Sammarinese".
It could simply be a challenge to enroll the severe patients in the US depending on their criteria. Tons of patients are ineligible, tons of patients are in overloaded hospitals that can't even manage the logistics of procuring masks, let alone a well controlled and documented trial.
Also, they are competing with 265 other trials actively recruiting in the US.
Also, they are competing with 265 other trials actively recruiting in the US.
It is very sad that we have 150k dead people in the world (34k in US) who could have produced more than 150x (35x) the data in experiments that weren't controversial, and saved many lives. Still, we'll probably have to wait for targeted medicine to really make a difference.
Many such trials are research and require extra planning, staff, researchers and equipment. Tests need to be rigorous, documented and are coordinated and shared via WHO among all countries.
I understand the staff and equipment part, but the plans & researchers were there already in the Chinese study that was cancelled because of lack of patients in China (BTW I haven't seen any news about the cancellation of the trial, which is very sad news).
In this research it looks to me like Gilead doesn't really want to show how (in)efficient remdesivir is in reality.
From 2400 participants there would have been enough for a control arm.
In this research it looks to me like Gilead doesn't really want to show how (in)efficient remdesivir is in reality.
From 2400 participants there would have been enough for a control arm.
No it's just a sign that they aren't comfortable running a full on controlled experiment yet. Only 2 deaths out of 113 severe in a week is far better than baseline.
There's also a recently released monkey study showing huge improvements, so it's more likely than not remdesivir works (https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1)
There's also a recently released monkey study showing huge improvements, so it's more likely than not remdesivir works (https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1)
Sounds promising, but have we completely ruled out the possibility that the baseline treatment causes most of the deaths?
At his wife’s urging, Michalak went to the University of Chicago Medicine hospital on Friday, April 3....and recovered enough to be discharged from the hospital on Tuesday, April 7.
That's pretty impressive to be a severe case of COVID and be discharged 4 days later.
That's pretty impressive to be a severe case of COVID and be discharged 4 days later.
Sounds better than typical but not "cherry-picked" either, for the people treated-- of 125 patients:
>She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.
So again, not conclusive, but sounds like it is surprising medical professionals used to seeing 10 day stays for COVID patients.
>She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.
So again, not conclusive, but sounds like it is surprising medical professionals used to seeing 10 day stays for COVID patients.
It happens regularly. COVID-19 patients need O2 for a few days and then are titrated back down to room air and discharged.
Company says their product test performance is great. News at 11.
Cautiously optimistic, let's hope and see. And not be too disappointed if this turns out to be nothing.
Cautiously optimistic, let's hope and see. And not be too disappointed if this turns out to be nothing.
If this goes sour...stock market go down arrow.
(It's been propped up on hopes treatments like this will work).
(It's been propped up on hopes treatments like this will work).
I've heard Gilead was a fake news hoax planted by Adam Feuerstein...
Stock futures are up 3% on this news so there appears to be something to this.
It’s an extremely difficult drug to manufacture and they may not be able to ramp it up in the next few months. Which is to say it’s good news for the second wave that’s coming but we can’t open up yet.
If it works well, and the only problem is manufacturing, there's an entire planet full of emergency-funded researchers and manufacturing engineers who would be very interested in solving the fast manufacturing problem.
It sounds a lot easier than the problem of finding good drugs in the first place, to be honest.
It sounds a lot easier than the problem of finding good drugs in the first place, to be honest.
It's now up 13%, and was up by 16% when NBC reported.
https://www.cnbc.com/2020/04/16/gilead-stock-surges-after-re...
https://www.cnbc.com/2020/04/16/gilead-stock-surges-after-re...
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3% in the futures market is just noise.
If you were doubting that the +3% market movement was primarily driven by this news, take a look at the markets at 12:40PM today when negative news of clinical trials for the drug were released. Again, direct minute by minute correlation btw SPY dropping and GILD news.
The rally from bottom isn't though. Infinite currency makes for risk on.
Gilead itself is up 16%, which would be a 52 week high.
> Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions. “It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison.
Here is some historical perspective about using placebos while people are getting infected and dying:
* https://rootsofprogress.org/polio-and-the-controversy-over-r...
* https://rootsofprogress.org/more-on-polio-and-randomized-cli...