[BostonCard]

We may have to wait a bit longer for that randomized, controlled (but open-label) study of hydroxychloroquine.

https://www.npr.org/sections/coronavirus...y-concerns

The WHO, which is running the largest trial of hydroxychloroquine, is temporarily halting the HCQ arm of the trial, in light of the new paper published in the Lancet.

"The steering committee met over the weekend, in the light of this uncertainty," Swaminathan says. "We decided we should be proactive, err on the side of caution and suspend enrollment temporarily into the hydroxychloroquine arm [of the Solidarity trial]."

The other arms of the trial (local standard of care, remdesivir, lopinavir/ritonavir, and lopinavir/ritonavir + interferon ß) are continuing.  My guess is that the WHO investigators will allow those who got hydroxychloroquine to make it to the primary endpoint (all cause mortality after 28 days), though it might do a partial data cut with the patients who have already made the endpoint.  It will then do a safety unblinding to see if mortality is higher in this group than in the standard treatment group.  If it is, then they will stop that arm for good; if it is not, they will re-open enrollment in the arm.  Depending on how many patients they have in that arm, they may also do a futility analysis and could stop that arm for futility.  There's an outside chance that they would also look for superiority, but the context makes me think that's unlikely.

My guess is that they will eventually resume the trial, but stay tuned.

BC

[BostonCard]

We may have to wait a bit longer for that randomized, controlled (but open-label) study of hydroxychloroquine.

https://www.npr.org/sections/coronavirus...y-concerns

The WHO, which is running the largest trial of hydroxychloroquine, is temporarily halting the HCQ arm of the trial, in light of the new paper published in the Lancet.

"The steering committee met over the weekend, in the light of this uncertainty," Swaminathan says. "We decided we should be proactive, err on the side of caution and suspend enrollment temporarily into the hydroxychloroquine arm [of the Solidarity trial]."

The other arms of the trial (local standard of care, remdesivir, lopinavir/ritonavir, and lopinavir/ritonavir + interferon ß) are continuing.  My guess is that the WHO investigators will allow those who got hydroxychloroquine to make it to the primary endpoint (all cause mortality after 28 days), though it might do a partial data cut with the patients who have already made the endpoint.  It will then do a safety unblinding to see if mortality is higher in this group than in the standard treatment group.  If it is, then they will stop that arm for good; if it is not, they will re-open enrollment in the arm.  Depending on how many patients they have in that arm, they may also do a futility analysis and could stop that arm for futility.  There's an outside chance that they would also look for superiority, but the context makes me think that's unlikely.

My guess is that they will eventually resume the trial, but stay tuned.

BC