Early research suggests that fluvoxamine, an FDA approved medication for depression and obsessive compulsive disorder, can be an effective early treatment for COVID-19. Fluvoxamine, created 37 years ago, is an inexpensive and widely available generic drug. It's in a class of drugs called Selective Serotonin-Reuptake Inhibitors (SSRIs). SSRIs appear to activate a central nervous system protein that plays a role in regulating inflammatory responses. Small clinical and observational studies show that repurposing fluvoxamine to treat coronavirus prevents some of the most serious complications related to inflammation, and keeps people from hospitalization.
Serendipity and Science
In March, as the coronavirus began to devastate the world, Dr. Nicolas Hoertel, associate professor of psychiatry at Paris University and a psychiatrist at a hospital in Paris, noticed that far fewer of his patients had symptomatic COVID-19 than did the caregivers in the unit. After consulting with other hospital employees around Paris, Dr. Hoertel and his colleagues published a large COVID-19 and the drug with the greatest sigma-1 activation in the study (fluoxetine in that case) had the greatest protection. The study states that antidepressants “could be associated with lower risk of death or intubation in hospitalized patients with COVID-19.”
At the same time, Angela Reiersen, a psychiatrist at Washington University in St. Louis was exploring a similar theory. Recalling research published in 2019 suggesting fluvoxamine reduced damaging aspects of the inflammatory response during sepsis, Dr. Reiersen wondered if the drug could have similar effects on Covid-19 patients. She teamed up with colleague Dr. Eric Lenze and developed a study design.
With support from CETF, a randomized, double-blind and fully remote outpatient clinical trial was conducted. The trial included 152 people, all of whom were 18 years or older, symptomatic, and diagnosed with mild forms of COVID-19. Participants were randomly assigned (1:1) to take either Fluvoxamine or a placebo. In this trial, of the 80 participants who received the drug, no patients hit the endpoint of clinical deterioration (defined as reaching blood oxygen saturation level of less than 92% and shortness of breath requiring supplemental oxygen), versus 6 people out of 72 who got the placebo and did reach the clinical endpoint.
In summary, all fluvoxamine-treated patients did not meet the study endpoint. The study appeared as the lead story in JAMA on November 12, 2020. The Editors noted that they chose this study from more than 10,000 COVID submissions received since February 2020. The study was the third-most popular article on JAMA for the month of December 2020.
Intrigued by these results, CETF founder Steve Kirsch accepted an invitation to discuss the findings on a weekly virtual meeting of the Harvard Business School Association of Northern California, which was led by Dr. David Seftel, the physician at Golden Gate Fields horse-racing track in Berkeley, CA.
On November 21, 2020, within days of the virtual Harvard meeting, a mass COVID-19 outbreak occurred at the racetrack, initially infecting 200 employees. After doing his own research and weighing the potential risks, Dr. Seftel decided to offer patients the option to take fluvoxamine. At first, only 35% of the employees opted to try the drug but after 2 weeks, 100% opted to take the drug. None of those 77 employees required hospitalization, compared with a 12.5% hospitalization rate for the 48 employees who declined the drug. In addition, after two weeks, none of the treatment group had any COVID-19 symptoms while 60% of the group who declined the drug had one or more COVID-19 symptoms (p-value<1e-14).
The Seftel study was published in OFID with a special "Editor's Choice" designation on February 1, 2021. The dose used in that study was significantly lower than in the Lenze study: only 50mg twice a day. At that dose, no side effects from the drug were reported by any of the participants and COVID-related symptoms resolved within an average of three days.
We have received many reports that fluvoxamine dosed at 50 mg twice a day has been successful in treating people with long haul COVID symptoms also known as Post-Acute Sequelae of SARS-CoV-2 infection (PASC). Washington University is currently evaluating whether to open a clinical trial for treating people with fluvoxamine for long-haul COVID.
Physicians who had been prescribing ivermectin plus supplements have reported markedly superior outcomes when adding fluvoxamine (50mg BID). There is no known interaction between the drugs.
On December 9, FastGrants sent this message to all grantees: "Given that fluvoxamine is relatively safe, cheap, and widely available, we’ve decided to issue a call for proposals and data pertaining to fluvoxamine. We are interested in funding any fluvoxamine RCTs that can be rapidly initiated or other relevant connected work. (We are already funding one RCT that should start soon.) If you have a related proposal, relevant data (on fluvoxamine, SSRIs, or S1R agonists more broadly), or know of anyone else who does, please also feel free to send them our way. We are eager to see both positive and negative data in this area."
On Jan 22, a key opinion leader panel (KOL) of 30 experts from NIH, CDC, and leading academic institutions met to review the evidence on fluvoxamine for COVID. They concluded that fluvoxamine should be added to the NIH Guideline. A vote after the meeting was 2:1 in favor of recommending physicians engage with patients in a process known as "shared decision making" for use of fluvoxamine to treat COVID. The meeting notes have been submitted for publication.
CETF, FastGrants, the Skoll Foundation, and Cures Within Reach are jointly sponsoring a larger Phase 3 trial of fluvoxamine that is actively recruiting participants. This is a remote trial that is available to anyone in the US and Canada.
The Together trial, funded by the Gates Foundation and Fast Grants, is studying fluvoxamine, ivermectin, and metformin. Preliminary results are expected by the end of March 2021.
Participating in this clinical trial is a great way to contribute to lifesaving research and the fight against COVID-19. There is no cost to enroll and you can participate from home (no hospital visits required).
See the Fluvoxamine information page at Washington University. In particular, patients should be warned about caffeine usage while taking fluvoxamine.
These medical experts have experience treating COVID-19 patients and are committed to considering the latest in medical advancements as part of a treatment plan, in partnership with individual patients.
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Column: Can a common antidepressant help in the fight against COVID-19? (Los Angeles Times)
These drugs might prevent severe COVID (Scientific American)