
NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced Covid-19 - vikramkr
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
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akimball
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)31022-9/fulltext)
is the gold standard placebo-controlled double-blind RCT. It shows no
significant benefits, substantial adverse effects. Also published today, but
no headlines

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vikramkr
The adverse effects are concerning, however, the lancet trial was underpowered
and had to be stopped early because there weren't enough patients [0]. That's
why they say in their interpretation that even though they saw some numerical
improvement in their results, larger trials are needed to evaluate statistical
significance. The NIAID's trial is also a placebo-controlled randomized
controlled trial and was adequately powered for reduction in recovery time,
but didn't hit statistical significance at a p<.05 threshold for mortality
rate.

[0][https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)31023-0/fulltext)

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vikramkr
I found this news exciting/significant because this is the first time we've
seen positive news about remdesivir in the context of a placebo controlled,
randomized, double blinded trial. Unlike prior trials that either didnt have a
control arm, or trials like the Lancet trial that was also released today that
were underpowered, this trial shows a statistically significant effect by
remdesivir. For context, the Lancet trial showed a numerical effect, but
couldn't recruit enough patients and was ultimately underpowered, so it wasnt
able to show statistical significance.

It's exciting that there's finally at least one drug with at least one fully
powered thousand plus patient placebo controlled trial with a statistically
significant impact. It shows the disease is drug gable and treatable, and is
not invulnerable, and is an exciting win for science.

Something else I'm excited about is the potential to use Remdesivir as a
preventative. Because it works by inhibiting viral replication, it could be
used as a preventative for high risk individuals until a vaccine is developed
or the disease is eradicated.

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hannob
This is the relevant sentence: "More detailed information about the trial
results, including more comprehensive data, will be available in a forthcoming
report."

This looks more like a press release and contains no details that would let
one evaluate how robust these results are.

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vikramkr
They also include changes to endpoint metrics with P values. While it's not
the full dataset, it's something.

"Preliminary results indicate that patients who received remdesivir had a 31%
faster time to recovery than those who received placebo (p<0.001).
Specifically, the median time to recovery was 11 days for patients treated
with remdesivir compared with 15 days for those who received placebo. Results
also suggested a survival benefit, with a mortality rate of 8.0% for the group
receiving remdesivir versus 11.6% for the placebo group (p=0.059)."

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xiphias2
,,Preliminary results indicate that patients who received remdesivir had a 31%
faster time to recovery than those who received placebo (p<0.001)."

This sentence doesn't make any sense. They should have at least published a
95% confidence interval in the difference or ratio between time to recovery.

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vikramkr
The conclusion you'd draw is the same using a P value and a confidence
interval. Having a statistically significant P value, meaning a P value less
than a given significance level, then implies that the confidence interval at
that significance level does not include the null hypothesis value.

If your significance level is .05 (meaning you are willing to accept a 5%
chance of a type 1 error in which you reject the null hypothesis incorrectly),
you can use either a confidence interval or a p value. You could look at a 95%
condfidence interval and see if the % faster time to recovery range includes
the null hypothesis of zero, or you could calculate a P value to see if it is
less than .05. Both of them will give you the same conclusion.

Based on the P values given, you know that the 95% confidence interval for %
faster time to recovery will not contain 0% (nor will the 99% interval or the
99.9% interval). But, the % difference in mortality at a 95% confidence
interval will contain zero, since p>.05.

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tgafpc2
Just want to remind everyone to be consistent. President Trump touted
Remdisivir while it was _not_ approved for treating C19 and had no clinical
trials.

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tapoxi
Trump was especially irresponsible in touting hydroxychloroquine because he
said it had very promising results, people have access to it now, there are no
adverse effects, and he was going to let everyone get a prescription for it.

You're also incorrect, remdesivir had already started clinical trials in early
March and patients were being enrolled. Trump made his comments ~2 weeks after
they had begun.

~~~
TMWNN
>Trump was especially irresponsible in touting hydroxychloroquine because he
said it had very promising results, people have access to it now, there are no
adverse effects, and he was going to let everyone get a prescription for it.

Rheumatologist with 30 years of experience who, while skeptical of
hydroxychloroquine's benefits for COVID19, has no problem with Trump's "what
have you got to lose?" statement:
[https://www.youtube.com/watch?v=hRCG9RtFJ_Y](https://www.youtube.com/watch?v=hRCG9RtFJ_Y)

