Alyosha,
The GILD "trial" is in many cases similar to ours. The quotes are due to the fact that the end point was changed mid-way . Better not to go into why and so on. Suffice to say it was "adaptive".
From their press release of their SIMPLE trial:
https://www.gilead.com/news-and-press/press-r...e-covid-19
Some comments here:
They had two groups, one with Remdesivir application for 5 days and ,another with application for 10 days. The study was for hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels Only the group with 5 days had improvement Vs placebo . The group with Remdesivir applied for 10 days didn't. This is not what one would expect.
From here the infamous words: "trending toward but not reaching statistical significance".
Now, how did they measure improvement ??. patients with more than 1 point and more than 2 points improvement in a 7-point ordinal scale at day 11 (R=Remdesivir P=Placebo):
70% vs 61% (R 5 days vs P) for >2 points
76% Vs 66% (R 5 days vs P) for >1 points
6% vs 11 % (R 5 days vs P) Requiring any oxygen support
3% vs 11% (R 5 days vs P) ≥1-point worsening in ordinal scale
51% vs 45% (R 5 days vs P) Any adverse event (AE)
10% vs 12% (R 5 days vs P) Grade ≥3 AE
4% vs 9% (R 5 days vs P) Any serious adverse event (SAE)
Some interesting facts here: There were more adverse effects in the Remdesivir group, however the Severe ones were less in the drug arm. Grade ≥3 were similar. The one large difference was that the placebo group worsened in 11% as compared with 3% for the Rem group.
That is why the reduction we had in the SAE's is so important. As you can see these results are not precisely "blowing it out of the water", and yet, they got emergency approval.
We should be able to do better than this easily.
The GILD "trial" is in many cases similar to ours. The quotes are due to the fact that the end point was changed mid-way . Better not to go into why and so on. Suffice to say it was "adaptive".
From their press release of their SIMPLE trial:
https://www.gilead.com/news-and-press/press-r...e-covid-19
Quote:The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group
Some comments here:
They had two groups, one with Remdesivir application for 5 days and ,another with application for 10 days. The study was for hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels Only the group with 5 days had improvement Vs placebo . The group with Remdesivir applied for 10 days didn't. This is not what one would expect.
Quote:The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance
From here the infamous words: "trending toward but not reaching statistical significance".
Now, how did they measure improvement ??. patients with more than 1 point and more than 2 points improvement in a 7-point ordinal scale at day 11 (R=Remdesivir P=Placebo):
70% vs 61% (R 5 days vs P) for >2 points
76% Vs 66% (R 5 days vs P) for >1 points
6% vs 11 % (R 5 days vs P) Requiring any oxygen support
3% vs 11% (R 5 days vs P) ≥1-point worsening in ordinal scale
51% vs 45% (R 5 days vs P) Any adverse event (AE)
10% vs 12% (R 5 days vs P) Grade ≥3 AE
4% vs 9% (R 5 days vs P) Any serious adverse event (SAE)
Some interesting facts here: There were more adverse effects in the Remdesivir group, however the Severe ones were less in the drug arm. Grade ≥3 were similar. The one large difference was that the placebo group worsened in 11% as compared with 3% for the Rem group.
That is why the reduction we had in the SAE's is so important. As you can see these results are not precisely "blowing it out of the water", and yet, they got emergency approval.
We should be able to do better than this easily.
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