Lonestar wrote: ↑
Fri Aug 14, 2020 2:47 pm
sophie wrote: ↑
Fri Aug 14, 2020 1:03 pm
I remember that Trump leaned on the FDA to authorize hcq use for prospective randomized clinical trials. But when reports of cardiac arrhythmias surfaced, the trials were stopped. There are a number of retrospective, correlative studies with mixed results but these aren’t helpful.
If Trump had ordered the FDA to reverse its decision, you can imagine how that would have been reported. Pretty sure the media would have trotted out the H word. So I don’t think he had much choice really.
I would think prospective studies, directed towards the indication of Covid, would take a very long time
Not so. A couple of months at most, if conducted in hospitals crammed with COVID patients. No industry sponsor needed because the drugs are generic and cheap. In fact, I'm involved with a trial involving a generic drug (unrelated to COVID) right now, aiming to recruit just 10 patients. Research faculty and divisions generally have existing funds that could have been raided to pay for the HCQ & placebo pills, or you could have written a quickie NIH administrative supplement. IRB protocols were being super-expedited taking maybe 2 or 3 days to approval. If there's a big effect you don't need more than a handful of patients (maybe 30 or 40) in each arm - the trials requiring thousands of patients are because the drug has a minimal effect or only a small number of people are expected to have the outcome you want to avoid (e.g. death). That number would have been recruited in about a day in NYC back in March, where the daily new case counts hit 7,000. Then you just wait for outcomes, which is a matter of a few weeks. Given the situation, a report at 1 or 2 weeks, e.g. # recovered vs. still on vent vs. died, would have been appropriate.
If I were an infectious disease faculty member that's totally what I would have done. Sure, you could follow up with a bigger study if the small one was inconclusive, and you would have needed a bigger study (maybe 100 in each arm) if you wanted to see what happened when you gave it to, say, members of vulnerable populations at initial presentation.
I remember thinking that someone must be doing all these things at my hospital. I'm incredulous that this wasn't the case. There were some retrospective studies but those are honestly worthless for all kinds of reasons.