Remdesivir showing early promise in Chicago study

[JamieDimonsBalls]

https://www.statnews.com/2020/04/16...uggests-patients-are-responding-to-treatment/

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.

The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

Id caution that another study of the drug did not seem to have the same effectiveness in Europe (can’t remember if France or Germany)

 

[Marvin the Martian]

It really is going to take a huge study, or a lot of small ones, to get a handle on what works. 100+ by itself cannot cut through the noise.

 

[JamieDimonsBalls]

It really is going to take a huge study, or a lot of small ones, to get a handle on what works. 100+ by itself cannot cut through the noise.

Yes

 

[HillzHoozier]

https://www.statnews.com/2020/04/16...uggests-patients-are-responding-to-treatment/

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.

The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

Id caution that another study of the drug did not seem to have the same effectiveness in Europe (can’t remember if France or Germany)

Yeah, but can you clean a fish tank with it?

 

[Ladoga]

It really is going to take a huge study, or a lot of small ones, to get a handle on what works. 100+ by itself cannot cut through the noise.[/QUOTE

There's a 2400 patient study going on now

 

[bawlmer]

Let's hope this holds. Some promising signs from a very reputable research hospital. Here are excerpts from Stat.

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.

Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

=========
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”

Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.​

 

[Morrison]

Let's hope this holds. Some promising signs from a very reputable research hospital. Here are excerpts from Stat.

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.

Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

=========
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”

Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.​

I work at Gilead and word on the street is we have the answer (remdesivir) but need to confirm with the various clinical trials, including placebo trials which will happen in May. I can’t tell you more or they will have to kill me.

 

[JamieDimonsBalls]

I work at Gilead and word on the street is we have the answer (remdesivir) but need to confirm with the various clinical trials, including placebo trials which will happen in May. I can’t tell you more or they will have to kill me.

Well, please don't get murdered (or fired), but thank you for the tidbit. Here is some more interesting data (I missed this one).

https://www.medicalnewstoday.com/ar...s-cov-2#New-evidence-in-support-of-remdesivir

 

[tooold4]

I work at Gilead and word on the street is we have the answer (remdesivir) but need to confirm with the various clinical trials, including placebo trials which will happen in May. I can’t tell you more or they will have to kill me.

Commitment issues?

 

[anon_mlxxvlbug9dpa]

I work at Gilead and word on the street is we have the answer (remdesivir) but need to confirm with the various clinical trials, including placebo trials which will happen in May. I can’t tell you more or they will have to kill me.

You must be the bogeyman if you work in big pharma

 

[Morrison]

You must be the bogeyman if you work in big pharma

Why do you think I kept that to myself all this time?

 

[tooold4]

Looks like Gilead is jumping from 75.00 to 90.00 a share overnight.

 

[bawlmer]

I work at Gilead and word on the street is we have the answer (remdesivir) but need to confirm with the various clinical trials, including placebo trials which will happen in May. I can’t tell you more or they will have to kill me.

If you haven't confirmed yet with trials then you don't have the answer. But the world is hoping you'll have plenty of good news very soon. The Stat article is the most encouraging thing I've read about COVID treatment so far, by a mile.

 

[Morrison]

Well, please don't get murdered (or fired), but thank you for the tidbit. Here is some more interesting data (I missed this one).

https://www.medicalnewstoday.com/ar...s-cov-2#New-evidence-in-support-of-remdesivir

The biggest obstacle is how elusive the virus is, so our scientists assumptions and the clinical trials are constantly being adjusted as more is learned about the virus on a daily basis, along with timing of when to administer the drug depending on the severity of the individual patient.

 

[anon_mlxxvlbug9dpa]

The biggest obstacle is how elusive the virus is, so our scientists assumptions and the clinical trials are constantly being adjusted as more is learned about the virus on a daily basis, along with timing of when to administer the drug depending on the severity of the individual patient.

Your leaders are idiots. Screw science. They just have to get Trump to declare it works and rubes everywhere will believe it.

 

[Marvin the Martian]

The biggest obstacle is how elusive the virus is, so our scientists assumptions and the clinical trials are constantly being adjusted as more is learned about the virus on a daily basis, along with timing of when to administer the drug depending on the severity of the individual patient.

Timing is probably a real trick, most antiviral meds need taken ASAP. Hopefully it works, it would be good to get a weapon.

 

[Morrison]

Your leaders are idiots. Screw science. They just have to get Trump to declare it works and rubes everywhere will believe it.

I’m not a scientist, I work in the real world there. But I can say our leader Dan O’Day is top notch (heard his meeting with Trump
didn’t go too well cause he told him the truth), and our scientists are world class.

 

[UncleMark]

You must be the bogeyman if you work in big pharma

I’m not a scientist, I work in the real world there.

Don't sell yourself short. Custodians play a critical role, especially in a medical or scientific setting.

 

[tooold4]

As far as the elusive virus and asymptomatic carriers go, the numbers from the good ship TR are just plain ugly.

https://news.yahoo.com/hundreds-sailors-carrier-roosevelt-covid-153906401.html

 

[Marvin the Martian]

As far as the elusive virus and asymptomatic carriers go, the numbers from the good ship TR are just plain ugly.

https://news.yahoo.com/hundreds-sailors-carrier-roosevelt-covid-153906401.html

That aspect is the one that would keep me up at night. That is the reason I don't see a way out of this without a vaccine. That and the amount of immunity one gets from having it be an open question.

 

[bawlmer]

Timing is probably a real trick, most antiviral meds need taken ASAP. Hopefully it works, it would be good to get a weapon.

I believe Remdesivir is an infusion, so it will be interesting at what point folks would be treated. But I doubt it will be everyone who tests positive. Maybe if things get worse after 7 days, which seems to be a critical juncture.

 

[tooold4]

That aspect is the one that would keep me up at night. That is the reason I don't see a way out of this without a vaccine. That and the amount of immunity one gets from having it be an open question.

Don't forget mutations and strains, if I'm awake everybody's awake!

 

[JamieDimonsBalls]

I believe Remdesivir is an infusion, so it will be interesting at what point folks would be treated. But I doubt it will be everyone who tests positive. Maybe if things get worse after 7 days, which seems to be a critical juncture.

Agreed. Doesn't seem sensible to treat everyone with symptoms, only those that actually need the drug to help them overcome the symptoms and worsening of them

 

[iuwclurker]

Would you rather die or perish?

 

[HillzHoozier]

Remdesivir Approval Status
Reviewed by Judith Stewart, BPharm Last updated on Apr 6, 2020.

FDA Approved: No
Generic name: remdesivir
Company: Gilead Sciences, Inc.
Treatment for: COVID-19

Remdesivir is an investigational antiviral compound undergoing clinical trials in China, the United States, and the United Kingdom as a potential treatment for COVID-19.

• Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.
• Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are coronaviruses structurally similar to SARS-CoV-2, the coronavirus that causes COVID-19.
• Novel Coronavirus (2019-nCoV) was first identified in the city of Wuhan, in China's Hubei province, in December 2019. On February 11, 2020, the World Health Organization (WHO) renamed the disease caused by the virus as COVID-19.

Edit: I really hope the trials go well because the sooner we get effective therapies, the sooner public fear is allayed. This one, considering non-approved status, just seems a long way off.

 

[Morrison]

Don't sell yourself short. Custodians play a critical role, especially in a medical or scientific setting.

Actually, I’m a facilities manager so I do have a large group of GMP custodians, along with a shit ton of other services-distribution (No, I don’t have any drugs for you), landscaping, pest control, maintenance, HVAC, electricians, you name it. Right now our focus is on distributing masks and emergency supplies all over the world. Gilead buys this stuff and donates it to various hospitals and first responder sites. Big Pharma sometimes do good things no one hears about. My group has distributed 1.4 million masks so far this week, as of yesterday.

 

[iuwclurker]

Actually, I’m a facilities manager so I do have a large group of GMP custodians, along with a shit ton of other services-distribution (No, I don’t have any drugs for you), landscaping, pest control, maintenance, HVAC, electricians, you name it. Right now our focus is on distributing masks and emergency supplies all over the world. Gilead buys this stuff and donates it to various hospitals and first responder sites. Big Pharma sometimes do good things no one hears about. My group has distributed 1.4 million masks so far this week, as of yesterday.

Prove it.

 

[bawlmer]

Remdesivir Approval Status
Reviewed by Judith Stewart, BPharm Last updated on Apr 6, 2020.

FDA Approved: No
Generic name: remdesivir
Company: Gilead Sciences, Inc.
Treatment for: COVID-19

Remdesivir is an investigational antiviral compound undergoing clinical trials in China, the United States, and the United Kingdom as a potential treatment for COVID-19.

• Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.
• Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are coronaviruses structurally similar to SARS-CoV-2, the coronavirus that causes COVID-19.
• Novel Coronavirus (2019-nCoV) was first identified in the city of Wuhan, in China's Hubei province, in December 2019. On February 11, 2020, the World Health Organization (WHO) renamed the disease caused by the virus as COVID-19.

It was approved by FDA for compassionate use (off-label) for COVID-19 but Gilead has since prioritized use in global clinical trials. Compassionate use is still available for pregnant women and children under 18.

 

[UncleMark]

Actually, I’m a facilities manager so I do have a large group of GMP custodians, along with a shit ton of other services-distribution (No, I don’t have any drugs for you), landscaping, pest control, maintenance, HVAC, electricians, you name it. Right now our focus is on distributing masks and emergency supplies all over the world. Gilead buys this stuff and donates it to various hospitals and first responder sites. Big Pharma sometimes do good things no one hears about. My group has distributed 1.4 million masks so far this week, as of yesterday.

Blah blah blah. Nobody likes a braggart.

 

[HillzHoozier]

It was approved by FDA for compassionate use (off-label) for COVID-19 but Gilead has since prioritized use in global clinical trials. Compassionate use is still available for pregnant women and children under 18.

Thanks. My googling is slow tonight. I hope this is successful!

 

[Morrison]

Blah blah blah. Nobody likes a braggart.

Maybe I do have some drugs for you.

 

[JamieDimonsBalls]

The biggest obstacle is how elusive the virus is, so our scientists assumptions and the clinical trials are constantly being adjusted as more is learned about the virus on a daily basis, along with timing of when to administer the drug depending on the severity of the individual patient.

This was the study I was concerned about, from NEJM. Perhaps the drugs needs to be administered sooner or this happened to be less effective in this small sample size.

https://blogs.sciencemag.org/pipeline/archives/2020/04/11/what-do-the-new-remdesivir-data-mean


Presented are data from 53 patients in the US, Canada, Europe, and Japan. They were in bad shape – 30 of them were on ventilators and 4 were receiving ECMO treatment (blood oxygenation outside the lungs). At the time of the manuscript’s preparation, 25 patients had been discharged from the hospital, and 7 had died (6 of whom had been on ventilation). Overall, clinical improvement was seen in 36 of the 53 patients.

Obviously nothing is going to work all of the time, but that clinical improvement number was lower than I (and others) were hoping for.

Hopefully, based on the UC data and eventually broader trials, it will turn out to be more of an anomaly.

 

[TheOriginalHappyGoat]

This was the study I was concerned about, from NEJM. Perhaps the drugs needs to be administered sooner or this happened to be less effective in this small sample size.

https://blogs.sciencemag.org/pipeline/archives/2020/04/11/what-do-the-new-remdesivir-data-mean


Presented are data from 53 patients in the US, Canada, Europe, and Japan. They were in bad shape – 30 of them were on ventilators and 4 were receiving ECMO treatment (blood oxygenation outside the lungs). At the time of the manuscript’s preparation, 25 patients had been discharged from the hospital, and 7 had died (6 of whom had been on ventilation). Overall, clinical improvement was seen in 36 of the 53 patients.

Obviously nothing is going to work all of the time, but that clinical improvement number was lower than I (and others) were hoping for.

Hopefully, based on the UC data and eventually broader trials, it will turn out to be more of an anomaly.

That's why patience is called for. You really don't know what a drug does until you have large-scale testing under strict experimental conditions.

 

[bawlmer]

I imagine timing is everything with an antiviral therapy. The NEJM study didn't collect viral load data, so it may be difficult to assess whether timing of starting therapy was a factor. Might be something to look at in future studies.

 

[GeorgeStrait IU]

https://www.statnews.com/2020/04/16...uggests-patients-are-responding-to-treatment/

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.

The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

Id caution that another study of the drug did not seem to have the same effectiveness in Europe (can’t remember if France or Germany)

They used this medication on “Emergency” yesterday on Cozi TV and Dr Kelly Bracket and Fire paramedic Gage were healed after the final commercial break. I believe it was for some kind of asian flu or something from a monkey.

 

[sglowrider]

That's why patience is called for. You really don't know what a drug does until you have large-scale testing under strict experimental conditions.

Drug development usually takes several years. I personally think this 18-months vaccine timeline that's getting talked about is creating ludicrous expectations for drug development --- and creating enormous pressure on pharma companies and regulators to cut as many corners as possible. Even the MERS vaccine is STILL in development - hasn't finished tests yet, 8 years on.

So maybe it’s possible to get a novel antiviral to market in record time too? I wouldn’t be top of the queue to take it, mind you. Antivirals are super tough to get right and often super toxic when they go wrong.

 

[Marvin the Martian]

Drug development usually takes several years. I personally think this 18-months vaccine timeline that's getting talked about is creating ludicrous expectations for drug development --- and creating enormous pressure on pharma companies and regulators to cut as many corners as possible. Even the MERS vaccine is STILL in development - hasn't finished tests yet, 8 years on.

So maybe it’s possible to get a novel antiviral to market in record time too? I wouldn’t be top of the queue to take it, mind you. Antivirals are super tough to get right and often super toxic when they go wrong.

A lead scientist for NIH was interviewed this week and said she expects a vaccine for first responders and medical workers this fall, and for everyone next spring. It sounds crazy, and I would imagine there would be big risks to it. If there is an issue with the vaccine, it will not be caught. Very seldom are unknown issues good things.

If on the other hand it gives me super powers...

 

[Standard Issue]

A lead scientist for NIH was interviewed this week and said she expects a vaccine for first responders and medical workers this fall, and for everyone next spring. It sounds crazy, and I would imagine there would be big risks to it. If there is an issue with the vaccine, it will not be caught. Very seldom are unknown issues good things.

If on the other hand it gives me super powers...

Is uncontrollable flatulence a super power ?

 

[JamieDimonsBalls]

They used this medication on “Emergency” yesterday on Cozi TV and Dr Kelly Bracket and Fire paramedic Gage were healed after the final commercial break. I believe it was for some kind of asian flu or something from a monkey.

I have no idea what this means

 

[IUJIM]

I have no idea what this means

I believe Emergency is a TV show