[dabigv13]

https://www.ft.com/content/ee9b611f-2b4b...b804d17a94

https://www.who.int/emergencies/diseases...treatments

Appears that the study has not been peer reviewed or published, but 2750 patients is pretty good sample size 
(unclear to me from the article if that is total who received remdesivir, or if that number includes patients who received placebo). The trial that got the EUA was 1063 patients total, the NIAID Adaptive trial, so this is much larger.

This is not surprising of course. The study that earned the medication an EUA only showed a small reduction in time to improvement, but did not show improvement in mortality. So we remain with only one medication that seems effective, dexamethasone. Cheap, widely available, been around a long time. Still no silver bullets.

[dabigv13]

https://www.ft.com/content/ee9b611f-2b4b...b804d17a94

https://www.who.int/emergencies/diseases...treatments

Appears that the study has not been peer reviewed or published, but 2750 patients is pretty good sample size 
(unclear to me from the article if that is total who received remdesivir, or if that number includes patients who received placebo). The trial that got the EUA was 1063 patients total, the NIAID Adaptive trial, so this is much larger.

This is not surprising of course. The study that earned the medication an EUA only showed a small reduction in time to improvement, but did not show improvement in mortality. So we remain with only one medication that seems effective, dexamethasone. Cheap, widely available, been around a long time. Still no silver bullets.

[lex24]

WHO says a lot of things.  As for me, “ We won’t get fooled again”.

[lex24]

WHO says a lot of things.  As for me, “ We won’t get fooled again”.

[dabigv13]

I Can't Explain any better apparently, but the WHO study only gives more numbers and confirmation to the other studies that haven't shown this medication to reduce mortality. Getting dizzy in the head and I'm feeling blue.

[dabigv13]

I Can't Explain any better apparently, but the WHO study only gives more numbers and confirmation to the other studies that haven't shown this medication to reduce mortality. Getting dizzy in the head and I'm feeling blue.

[BostonCard]

Saying "the WHO says..." is different than "The WHO sponsored a study that showed..." which is what we are really talking about here.  However, all we have is an FT article purporting to have seen a draft of the paper, not even the preprint.  I think it would be better to wait and see what the article actually says.

BC

[BostonCard]

Saying "the WHO says..." is different than "The WHO sponsored a study that showed..." which is what we are really talking about here.  However, all we have is an FT article purporting to have seen a draft of the paper, not even the preprint.  I think it would be better to wait and see what the article actually says.

BC

[BostonCard]

The preprint paper is out:

https://www.medrxiv.org/content/10.1101/...1.full.pdf

With the caveat that it hasn't been peer reviewed, the mortality data for remdisivir looks very negative.  Not even a trend towards an improvement.  The figure on Page 15, with the two curves on top of one another, tells the story.

The authors also did a meta analysis for mortality (figure 4), incorporating all of the remdisivir studies (there have been four with reported data: Solidarity (this one) ACTT, and two smaller ones).  There might be a small benefit in low risk groups, but things look, if anything, worse in the high risk groups.

There are4 trials of Remdesivir vs the same management without it: Solidarity (604 deaths in about 5000 randomized), ACTT-1 (136 deaths in about 1000) and two smaller trials (41 deaths).5-7 Figure 4 gives mortality results from each trial, subdivided by initial respiratory support. (These like-vs-like comparisonsallow for the proportion already on high-flow oxygen or ventilation at entry into ACTT-1 having been, by chance, somewhat lower with Remdesivir than with placebo.)  Combining dataappropriatelyfrom all 4 trials,8the Remdesivir vs control death rate ratio (RR) is 0.91 (95% CI 0.79-1.05).Interpretation should chiefly reflect not the p-value (p=0.21) or point estimate (RR=0.91) but the confidence interval (0.79-1.05), which shows the range of death rate ratios comfortably compatible with the weighted average of the findings from all trials. This absolutely excludes the suggestion that Remdesivir can prevent a substantial fraction of all deaths. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths, but is also comfortably compatible with prevention of no deaths (which would be consistent with the apparent lack of any reduction by Remdesivir in the initiation of ventilation or the duration of hospitalization in Solidarity).

I'll translate: we can't completely exclude an effect, but if there, it is pretty small.

BC

[BostonCard]

The preprint paper is out:

https://www.medrxiv.org/content/10.1101/...1.full.pdf

With the caveat that it hasn't been peer reviewed, the mortality data for remdisivir looks very negative.  Not even a trend towards an improvement.  The figure on Page 15, with the two curves on top of one another, tells the story.

The authors also did a meta analysis for mortality (figure 4), incorporating all of the remdisivir studies (there have been four with reported data: Solidarity (this one) ACTT, and two smaller ones).  There might be a small benefit in low risk groups, but things look, if anything, worse in the high risk groups.

There are4 trials of Remdesivir vs the same management without it: Solidarity (604 deaths in about 5000 randomized), ACTT-1 (136 deaths in about 1000) and two smaller trials (41 deaths).5-7 Figure 4 gives mortality results from each trial, subdivided by initial respiratory support. (These like-vs-like comparisonsallow for the proportion already on high-flow oxygen or ventilation at entry into ACTT-1 having been, by chance, somewhat lower with Remdesivir than with placebo.)  Combining dataappropriatelyfrom all 4 trials,8the Remdesivir vs control death rate ratio (RR) is 0.91 (95% CI 0.79-1.05).Interpretation should chiefly reflect not the p-value (p=0.21) or point estimate (RR=0.91) but the confidence interval (0.79-1.05), which shows the range of death rate ratios comfortably compatible with the weighted average of the findings from all trials. This absolutely excludes the suggestion that Remdesivir can prevent a substantial fraction of all deaths. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths, but is also comfortably compatible with prevention of no deaths (which would be consistent with the apparent lack of any reduction by Remdesivir in the initiation of ventilation or the duration of hospitalization in Solidarity).

I'll translate: we can't completely exclude an effect, but if there, it is pretty small.

BC

[dabigv13]

Solidarity is about 5 times bigger than the ACTT trial, so we'd know if it was saving lives. Gilead is making a pile though. Also interesting that the much larger trial did not show a decrease in hospitalization, the reason for the EUA by the FDA and if IIRC, it was not stopped at an original endpoint of the study, but one that was decided on after the trial had already started. Not necessarily fishy, but could be a sign of cherry picking good looking data to justify an early end.

Disheartening. I'm just hoping one of the vaccines pans out, but science is sobering.

[dabigv13]

Solidarity is about 5 times bigger than the ACTT trial, so we'd know if it was saving lives. Gilead is making a pile though. Also interesting that the much larger trial did not show a decrease in hospitalization, the reason for the EUA by the FDA and if IIRC, it was not stopped at an original endpoint of the study, but one that was decided on after the trial had already started. Not necessarily fishy, but could be a sign of cherry picking good looking data to justify an early end.

Disheartening. I'm just hoping one of the vaccines pans out, but science is sobering.

[BostonCard]

Solidarity is about 5 times bigger than the ACTT trial, so we'd know if it was saving lives. Gilead is making a pile though. Also interesting that the much larger trial did not show a decrease in hospitalization, the reason for the EUA by the FDA and if IIRC, it was not stopped at an original endpoint of the study, but one that was decided on after the trial had already started. Not necessarily fishy, but could be a sign of cherry picking good looking data to justify an early end.

Disheartening. I'm just hoping one of the vaccines pans out, but science is sobering.

Rember ACTT was run by the NIH, not Gilead.  I'm going to speculate here, but my guess is that ACTT recalculated the power after they looked at the number of events and concluded that the effect magnitude would have to be massive for them to move mortality.

BC

[BostonCard]

Solidarity is about 5 times bigger than the ACTT trial, so we'd know if it was saving lives. Gilead is making a pile though. Also interesting that the much larger trial did not show a decrease in hospitalization, the reason for the EUA by the FDA and if IIRC, it was not stopped at an original endpoint of the study, but one that was decided on after the trial had already started. Not necessarily fishy, but could be a sign of cherry picking good looking data to justify an early end.

Disheartening. I'm just hoping one of the vaccines pans out, but science is sobering.

Rember ACTT was run by the NIH, not Gilead.  I'm going to speculate here, but my guess is that ACTT recalculated the power after they looked at the number of events and concluded that the effect magnitude would have to be massive for them to move mortality.

BC