Gilead announced that remdesivir hit it's primary endpoint in an NIH trial. This is in contrast to their failed trial in China. Likely the main difference is that the drug is given earlier and to less severe cases than they tried in China.
The primary endpoint is time to recovery at day 29, meaning that they treated patients with remdesivir or placebo for a month and then compared how long it took to be considered "recovered". A patient is considered recovered if they meet at least one of the following criteria:
1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
They changed their definition of "recovery" compared to the China trial as well, which I found odd. So in this trial a patient can remain hospitalized on oxygen and be considered "recovered". I do understand the difficulty in selecting study objectives since this disease is so new, so I don't want to be too critical.
It's promising and suggests that early intervention could provide some benefit. I would wait for the NIAID official announcement with some actual numbers, because it's possible to meet this endpoint without actually improving the death rate. A clue about the "true" effectiveness will be how open NIAID and Gilead are with key statistics such as death rate, incodence of progression to severe disease, etc.
The reason I'm a little skeptical is because they buried some of these important readouts within twenty-eight (28!!!) secondary readouts, which means they are fishing for any positive data. Even if you compared two placebos, with 28 different readouts you almost expect one or two of them to hit significance, especially if you do what's called "hypothesis-generating" analysis to prevent all these comparisons from destroying your statistical power.
This treatment also requires daily IV infusions for 5-10 days, which means it's pretty much only suitable for patients who need a week or longer in the hospital anyways.
Tl;dr: this is great news because it's the first real, blinded, controlled data suggesting any therapeutic benefit. HOWEVER, approach with very cautious optimism due to many reasons described above that. A cure this is not.
The primary endpoint is time to recovery at day 29, meaning that they treated patients with remdesivir or placebo for a month and then compared how long it took to be considered "recovered". A patient is considered recovered if they meet at least one of the following criteria:
1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
They changed their definition of "recovery" compared to the China trial as well, which I found odd. So in this trial a patient can remain hospitalized on oxygen and be considered "recovered". I do understand the difficulty in selecting study objectives since this disease is so new, so I don't want to be too critical.
It's promising and suggests that early intervention could provide some benefit. I would wait for the NIAID official announcement with some actual numbers, because it's possible to meet this endpoint without actually improving the death rate. A clue about the "true" effectiveness will be how open NIAID and Gilead are with key statistics such as death rate, incodence of progression to severe disease, etc.
The reason I'm a little skeptical is because they buried some of these important readouts within twenty-eight (28!!!) secondary readouts, which means they are fishing for any positive data. Even if you compared two placebos, with 28 different readouts you almost expect one or two of them to hit significance, especially if you do what's called "hypothesis-generating" analysis to prevent all these comparisons from destroying your statistical power.
This treatment also requires daily IV infusions for 5-10 days, which means it's pretty much only suitable for patients who need a week or longer in the hospital anyways.
Tl;dr: this is great news because it's the first real, blinded, controlled data suggesting any therapeutic benefit. HOWEVER, approach with very cautious optimism due to many reasons described above that. A cure this is not.
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