When Did The TOGETHER Ivermectin And Fluvoxamine Trials End?
You’d think, of all the unanswered questions around the TOGETHER trial, at the very least we would be able to answer this one. I hate to disappoint, but the answer is… maybe? Or maybe not.
This is a short article just to get this odd finding out there—as I’m not sure it will lead to anything bigger—but it’s baffling enough that I also don’t want it to just live in my notes forever.
The Official Answer
If we look at the published papers, the answer is (somewhat) straightforward.
For ivermectin, we have the following two bits:
I mean, it’s kinda weird that the Data and Safety Monitoring Committee (DSMC) recommended it be stopped on August 5, but they still let patients in for another day—but it’s probably nothing. Moving on to fluvoxamine…
OK then. On August 5, 2021, the DSMC meets, decides to terminate both fluvoxamine and ivermectin. That’s reasonably simple, right?
The More Official Answer
Not… quite. You see, if we look at the master protocol—the document that is approved by the Canadian authorities—we see that…
So… the ivermectin and fluvoxamine arms were closed on July 26, 2021? That’s a full 10 days before the DSMC met, according to the published papers. Maybe the website of the trial has interesting hints for us?
Interim analysis, July 2021. So, it agrees with the protocols, but not with the published papers. If the DSMC didn’t make the decision to close the arms to enrollment… who did?
According to the protocol, even the interim analyses are supposed to be blind—and even then, only the DSMC is supposed to see them and convey its decisions to the Steering Committee (the investigators):
Either the blinding in the trial was non-existent—with the Steering Committee having full access to the data of the trial as it was ongoing—or the website and the master protocols of the trial were wrong. By the way, both versions of the master protocol that have these dates on them were submitted to and approved by the Canadian IRB (specifically to HiREB—Hamilton Integrated Research Ethics Board, McMaster University).
As always, if only the trial would release its raw data for audit, we wouldn’t have to read the tea leaves. But as things stand, it is almost impossible to make any single document that comes out of this trial agree with any other document on things as fundamental as when the various arms were started, or when they were ended.