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Trials of fluvoxamine for covid-19

Interview and article by Christine Clark.

Early treatment of covid-19 with fluvoxamine has been remarkably effective in two trials, one of which was funded by the Covid-19 Early Treatment Fund (CETF). IMI spoke to Steve Kirsch, entrepreneur, philanthropist, founder and CEO of the CETF to find out more.

In the early days of the pandemic doctors and researchers advised Mr Kirsch that repurposing of existing drugs would be the fastest way to end the pandemic. However, research in this area was not funded. He set up the Covid-19 Early Treatment Fund (CETF) to support outpatient clinical trials for effective early treatments for COVID-19, using existing drugs. Specifically, the CETF’s mission is to find an existing drug or drug combination that, when given early, reduces hospitalisation and fatality rates by 75% or more.

The CETF has funded two randomised, controlled trials of fluvoxamine for early covid-19. The first was a phase 2 trial that included 152 patients1 with early covid-19 and the second (Stop Covid 2) was a phase 3 trial, expected to enrol about 1000 patients that has not reported yet.  There has also been an observational, quasi-randomised study including 113 patients, reported by Seftel and Boulware.2  Both the phase 2 trial and the Seftel and Boulware study reported a 100% effect size, notes Mr Kirsch.  He expects that the phase 3 trial will report an effect size of less than 100% because the drug has been given later in the course of the disease. “If you give [the drug] late it has much less of an effect so we always encourage people to give drugs early on. A virus is like a fire if you have a fire in your house you don’t wait to call the fire department,  you put water on fire as soon as you can because the fire is smaller…”, he says. Early treatment following an effective protocol is critical. “When you have trials where the drug delivery was delayed you should expect that instead of getting 100%, 90% or 80% you might get something like 30-40%; a day can make a big difference”, he adds.

In fact the phase 3 trial of fluvoxamine in the US has just been halted – and there results (and the reason for halting of the trial) are eagerly anticipated.

One other trial involving fluvoxamine is the Together trial. Results are expected in about three months.

$1 million reward

Mr Kirsch has offered a reward of $1 million research grant to anyone who can demonstrate, based on the data, that fluvoxamine does not work. So far, he is confident that he will not lose his money.

References

  1. Lenze EJ et al. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19. A Randomized Clinical Trial. JAMA. 2020;324:2292-2300. doi:10.1001/jama.2020.22760
  2. Seftel S, Boulware DR. Prospective cohort of fluvoxamine for early treatment of COVID-19. Open Forum Infect Dis 2021;8.

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