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I& #39;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& #39;s the RCT"?
Well, this will not further pacify you. <thread> https://www.nejm.org/doi/full/10.1056/NEJMoa2007016">https://www.nejm.org/doi/full/...
Well, this will not further pacify you. <thread> https://www.nejm.org/doi/full/10.1056/NEJMoa2007016">https://www.nejm.org/doi/full/...
A quick check of http://clinicaltrials.gov"> 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/... https://clinicaltrials.gov/ct2/show/NCT04335123">https://clinicaltrials.gov/ct2/show/...
https://clinicaltrials.gov/ct2/show/NCT03719586">https://clinicaltrials.gov/ct2/show/... https://clinicaltrials.gov/ct2/show/NCT04335123">https://clinicaltrials.gov/ct2/show/...
Where are the RCTs for which we are hoping? Well, two are in China. I won& #39;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/... https://clinicaltrials.gov/ct2/show/NCT04252664">https://clinicaltrials.gov/ct2/show/...
https://clinicaltrials.gov/ct2/show/NCT04257656">https://clinicaltrials.gov/ct2/show/... https://clinicaltrials.gov/ct2/show/NCT04252664">https://clinicaltrials.gov/ct2/show/...
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& #39;T getting is a placebo-control, at least for severe #covid19: https://clinicaltrials.gov/ct2/show/NCT04292899">https://clinicaltrials.gov/ct2/show/...
This is what should make your head explode – a massively-funded undertaking where we& #39;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">https://clinicaltrials.gov/ct2/show/...
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">https://clinicaltrials.gov/ct2/show/...
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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