This study is a common citation of ivermectin believers, has been reported widely, and I think is a great teaching tool in how little effort it takes to be critical about research findings 1/npic.twitter.com/YDZNB1JP5R
Epidemiologist. Writer (Guardian, Observer etc). "Well known research trouble-maker". PhDing at @UoW Host of @senscipod Email gidmk.healthnerd@gmail.com he/him
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This study is a common citation of ivermectin believers, has been reported widely, and I think is a great teaching tool in how little effort it takes to be critical about research findings 1/npic.twitter.com/YDZNB1JP5R
2/n The study is here, and has an objectively large impact with nearly a dozen news stories and an Altmetric of 2750https://www.medrxiv.org/content/10.1101/2021.05.31.21258081v1 …
3/n The study is pretty simple - 116 people with Covid-19, randomized to either receive ivermectin or a placebo Reported results were viral load, and more specifically proportion of people with Ct>30 at various time points on PCRpic.twitter.com/ozXyxZwAOj
4/n The authors report a marginally significant benefit at various days using an uncorrected logistic regression, and from this the massive attention sprangpic.twitter.com/5xk5vLDkrH
5/n One of the first things I do when I read randomized trials like this is look at their pre-registration. This is basically what the authors SAID they would do registered BEFORE they did it Here's the pre-reg for this trial:https://clinicaltrials.gov/ct2/show/NCT04429711?term=NCT04429711&draw=2&rank=1 …
6/n Immediately on looking at the pre-registration, there is a HUGE discrepancy with the published results Here's what the authors pre-registered as their exclusion and the flow chart from the study. Notice the difference?pic.twitter.com/eMFPtwG9Y6
7/n It appears that the authors have added an extra exclusion criteria that is applied AFTER randomization and treatment. This is "tested Ct>35" in the first two testspic.twitter.com/V5ZfCZWhv7
8/n Based on the protocol, that implies the sequence of events went like this: 1. patient tests positive, randomized and started treatment 2. Day 2, patient tests Ct>35 3. Day 4, patient tests Ct>35
9/n This is an issue for two reasons - firstly, it's not what the authors said they'd do. Secondly, it means that they are excluding people WHO MEET THEIR PRIMARY OUTCOME (i.e. Ct>30) after randomization and treatment has started
While it might be reasonable to exclude those meeting the primary endpoint at baseline, this is not what is being done. They are including those w/ 30-35 PCR Ct, who then immediately meet the primary endpoint. When was this decision made? Is it specified in the protocol? SAP?
I cannot find a timeline of the decision-making, although hard to see how it could've been before the study started
It's a pandemic, sometimes one doesn't know everything upfront. Thus, I give them a pass on needing to adapt -- that's fine. BUT -- one has to be VERY transparent in reporting when changes are made after a trial starts.
If one updates the clinicaltrials gov listing, then there is a record of the timeline. If changes are made, updating clinicaltrials gov is standard expectation for FDA IND or NIH trials.
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