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I've seen a lot of irritation and frustration for @NEJM and their publication of an uncontrolled case series of #covid19 patients treated with #remdesivir – saying, "great, where's the RCT"?
Well, this will not further pacify you. <thread> https://www.nejm.org/doi/full/10.1056/NEJMoa2007016
Well, this will not further pacify you. <thread> https://www.nejm.org/doi/full/10.1056/NEJMoa2007016
A quick check of http://clinicaltrials.gov reveals 12 trials registered. Two are "expanded access" protocols, basically the compassionate use described in the @NEJM article.
One is from the NIH for Ebola. One is a trial from University of Kansas for losartan in #covid19 that mentions remdesivir in its protocol:
https://clinicaltrials.gov/ct2/show/NCT03719586 https://clinicaltrials.gov/ct2/show/NCT04335123
https://clinicaltrials.gov/ct2/show/NCT03719586 https://clinicaltrials.gov/ct2/show/NCT04335123
Where are the RCTs for which we are hoping? Well, two are in China. I won't impugn their scientific validity without seeing final publication, but the protocols posted are a little sparse:
https://clinicaltrials.gov/ct2/show/NCT04257656 https://clinicaltrials.gov/ct2/show/NCT04252664
https://clinicaltrials.gov/ct2/show/NCT04257656 https://clinicaltrials.gov/ct2/show/NCT04252664
Finally, what are we going to get from $GILD to follow-up their preprint in @NEJM? They have two trials underway – and what we AREN'T getting is a placebo-control, at least for severe #covid19: https://clinicaltrials.gov/ct2/show/NCT04292899
This is what should make your head explode – a massively-funded undertaking where we'll just throw more bad data at the question. This is where we rightly criticize pharma for failing to randomize.
You can have stopping rules, safety monitoring, etc. to help prevent a trial from moving forward in which harms are being observed in one of the arms, but this is not useful – except for safety, but that question can be answered in an RCT, as well.
They do, at least, have a placebo-controlled version for those with moderate disease – those not mechanically ventilated, comparing 5 days, to 10 days, to "standard of care": https://clinicaltrials.gov/ct2/show/NCT04292730
Our best information may come out of France, which is testing multiple treatments – remdesivir, lopinavir/ritonavir, interferon beta-1A, and hydroxychloroquine – against each other in a large trial: https://clinicaltrials.gov/ct2/show/NCT04315948
But, if you looked at this recent NEJM article and were hoping this were an isolated piece of uninformative data from a sponsored trial, history has not taught you well.
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