Coronavirus (COVID-19)

[mission27]

8 minutes ago, ramssuperbowl99 said:

One group running into adverse events and the other not running into any unexpected new safety issues despite being given virtually the same regimen doesn't make sense.

Something doesn't add up. Which isn't to say I'm dismissing these results, it just doesn't make sense.

Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients.

Is this really evidence of adverse effects?  Doesnt seem statistically significant to me.

[ramssuperbowl99]

3 minutes ago, mission27 said:

Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients.

Is this really evidence of adverse effects?  Doesnt seem statistically significant to me.

It may not be the percentage of people with adverse events but specific, more dangerous types of adverse events that caused them to stop the study:

Quote

Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.

You'd have to look more into the specific data to really figure it out.

[seriously27]

2 minutes ago, mission27 said:

Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients.

Is this really evidence of adverse effects?  Doesnt seem statistically significant to me.

It's not significant. A 16% difference is adverse event pronouncements would warrant additional studies in almost all research facilities.  The number of patients doesn't matter, only the percentages for this specific study. 

[ramssuperbowl99]

4 minutes ago, ramssuperbowl99 said:

It may not be the percentage of people with adverse events but specific, more dangerous types of adverse events that caused them to stop the study:

You'd have to look more into the specific data to really figure it out.

Just read the whole thing. This isn't it. They separated out the more severe AEs and there still wasn't a difference.

[mission27]

Quote

White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news.”

Speaking to reporters from the White House, Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.”

 

U.S. health officials are expected to release the full results of a drug trial conducted by the National Institute of Allergy and Infectious Diseases later Wednesday. Gilead Sciences announced earlier in the day that the study had met its primary endpoint, but did not provide further details.

https://www.cnbc.com/2020/04/29/dr-anthony-fauci-says-data-from-remdesivir-coronavirus-drug-trial-shows-quite-good-news.html

I think this is the other study Gilead was referencing 

This is awesome

[mission27]

5 minutes ago, ramssuperbowl99 said:

Just read the whole thing. This isn't it. They separated out the more severe AEs and there still wasn't a difference.

I think the issue with the study was efficacy, not adverse effects?

Either way we now have two larger scale controlled studies showing highly positive results and Fauci is on board.  MoL is going to take the W

 

[seriously27]

3 minutes ago, mission27 said:

https://www.cnbc.com/2020/04/29/dr-anthony-fauci-says-data-from-remdesivir-coronavirus-drug-trial-shows-quite-good-news.html

I think this is the other study Gilead was referencing 

This is awesome

I would worry about this a little bit when combining this with the other study due to the fact that it was a single arm study. It's not done in connection with a placebo in this case so you can't compare the people getting better with people who did not take the drug at all. I'd love for this to work but right now I would say this drug needs a lot more testing before it shows to be effective. 

[ramssuperbowl99]

4 minutes ago, mission27 said:

I think the issue with the study was efficacy, not adverse effects?

Either way we now have two larger scale controlled studies showing highly positive results and Fauci is on board.  MoL is going to take the W

 

I don't know if it's limited to one issue. They seem focused very heavily on the adverse events and safety issues, but the study didn't hit the required statistical significance they originally planned for because they weren't able to recruit patients after March 12th due to the lack of cases in Wuhan.

Edited April 29, 2020 by ramssuperbowl99

[mission27]

4 minutes ago, seriously27 said:

I would worry about this a little bit when combining this with the other study due to the fact that it was a single arm study. It's not done in connection with a placebo in this case so you can't compare the people getting better with people who did not take the drug at all. I'd love for this to work but right now I would say this drug needs a lot more testing before it shows to be effective. 

Are they both single arm studies or just the Gilead one? 

For some reason I thought NIH study had a control group but could be wrong

[mission27]

Just now, mission27 said:

Are they both single arm studies or just the Gilead one? 

For some reason I thought NIH study had a control group but could be wrong

Either way, we have so much data on typical outcomes for hospitalized patients, I get its not perfect but its not a traditional situation

[mission27]

3 minutes ago, mission27 said:

9 minutes ago, seriously27 said:

I would worry about this a little bit when combining this with the other study due to the fact that it was a single arm study. It's not done in connection with a placebo in this case so you can't compare the people getting better with people who did not take the drug at all. I'd love for this to work but right now I would say this drug needs a lot more testing before it shows to be effective. 

Are they both single arm studies or just the Gilead one? 

For some reason I thought NIH study had a control group but could be wrong

Quote

The NIAID study is the most rigorous test to date of the potential treatment because it is a double-blind, placebo-controlled trial, the gold standard for seeing if a drug is safe and effective. A cohort of patients receive a dummy treatment instead of the real drug, without patients and treating doctors knowing which one the patients are getting. It provides the best comparison of how people treated with the drug fared in relation to those who did not get the drug.

 

The article I posted was a little confusing but I think what they're saying is the Gilead study is not placebo controlled.  The NIH study was and Fauci and Gilead are now both saying results are very positive 

[seriously27]

1 minute ago, mission27 said:

Are they both single arm studies or just the Gilead one? 

For some reason I thought NIH study had a control group but could be wrong

The study Fauci was referencing was a single arm study while the initial study referenced was a placebo study. The placebo study was necessary but unfortunately didn't show the results needed to be promising for the drug. They would need to do another round with more people to hopefully get the results they need to continue testing. 

I agree it's not a traditional situation but they will still need to show a better result than they have shown for them to proceed. 

[mission27]

1 minute ago, seriously27 said:

The study Fauci was referencing was a single arm study while the initial study referenced was a placebo study. The placebo study was necessary but unfortunately didn't show the results needed to be promising for the drug. They would need to do another round with more people to hopefully get the results they need to continue testing. 

I agree it's not a traditional situation but they will still need to show a better result than they have shown for them to proceed. 

They announced preliminary results of two studies today, one conducted by Gilead and one by NIAID

I think the former was single arm and the later was controlled?

There was a third study leaked last week that was also controlled but that was conducted in China and wasn’t related to either of these. That was the one with less positive results 

Fauci was actually speaking to the results of the NIAID study I believe. 

[ramssuperbowl99]

1 minute ago, seriously27 said:

The study Fauci was referencing was a single arm study while the initial study referenced was a placebo study. The placebo study was necessary but unfortunately didn't show the results needed to be promising for the drug. They would need to do another round with more people to hopefully get the results they need to continue testing. 

I agree it's not a traditional situation but they will still need to show a better result than they have shown for them to proceed. 

@mission27 and I a while ago were talking about the "goldilocks zone" where you have enough data that appears promising enough where you can be more confident than not that there are benefits to the drug before you have the statistical proof. It's a risk, but it's an educated risk and this is a pandemic.

I think this is the goldilocks zone.

[diehardlionfan]

42 minutes ago, mission27 said:

Perhaps, but that wouldn't explain why colder climates like NYC, Canada, London, Russia, Scandinavia, and Eastern Europe were hit later than warmer climates like Italy, Spain, Washington State, and parts of Asia.  Its not really explainable by travel patterns.  It could be a coincidence but there is circumstantial evidence IMO that the disease is thriving between 35-50 F and spreads more slowly in warmer or much colder environments

Was reading last night about an Israeli epidemiologist who compared these outbreaks and his position is that the outbreaks all tend to eb and flow within ~70 days regardless of lockdown measures (although the total amount of cases at any given time may be higher without a lockdown, the timeline of peak and downswing is similar no matter what you do).  He wasnt sure why although he did mention seasonality as a potential factor along with herd immunity within clusters.  Temperate climates go through ~2 months in the late winter where temperatures are in this ideal range for spread and you can see this disease hitting large cities across the northern hemisphere in a clean wave as each of these cities went through that band of temperatures 

If you followed Canadas outbreak the Toronto cases were traced directly to travel to and from Iran. On the west coast over 20,000 people travelled from Wuhan to the greater Vancouver area before travel restrictions. In Canada’s case it’s all related to travel.