Fluvoxamine and COVID-19: Here’s How the OCD Drug Might Help Prevent COVID-19 Infections From Getting Worse (September 2022)
Developed 40 years ago as an antidepressant, fluvoxamine—sometimes known as
Luvox (brand name)—has been used mainly to treat obsessive-compulsive disorder
(OCD), per the National Alliance on Mental Illness (NAMI).
Many existing drugs like the ones in C19Early.com have been used to treat COVID and often initial reports show success. However, there's concern that these studies took place before the rise of the Omicron variant of COVID-19, which has rendered certain prior treatments ineffective, such as GlaxoSmithKline’s sotrovimab. That newfound inefficacy led to the FDA revoking its emergency use authorization for the drug.
In December 2021, Dr. David R Boulware requested an emergency use authorization for the outpatient treatment of adults testing positive for SARS-CoV-2 to prevent progression to severe symptoms based on early efficacy data from the fluvoxamine trials. The Food and Drug Administration denied his request, listing concerns such as insufficient data.
That said, combining fluvoxamine and melatonin may significantly increase
the blood levels and effects of melatonin (Drugs.com). You can check for other potential drug interactions with fluvoxamine
at
Fluvoxamine Drug Interactions
- Drugs.com.
Most of the component treatments in the I-CARE protocol have various mode of actions and may not be affected by the changes in the Omicron variant spike protein.
Disclaimer: Please do not consider this article as personal medical advice, but as a recommendation for use by professional providers. Consult with your trusted doctor and discuss with her/him.
References:
The information in this article is accurate as of press time.
However, as the situation surrounding COVID-19 continues to evolve,
it's possible that some data have changed since publication. We
encourage readers to stay informed on news and recommendations for
their own communities by using the
CDC,
WHO, and their local public health department as resources.
A meta-analysis of three previous trials on the drug’s effectiveness for
COVID-19 treatment found “a high probability of being associated with
reduced hospitalization in outpatients with COVID-19,” a study (April 2022) led by researchers from McGill University in
Quebec, Canada, found.
The researchers report that fluvoxamine treatment appeared to reduce the risk of severe COVID-19 by about 25 percent if given to people at high risk for COVID-19 early in the course of their infection.
That’s significantly less effective than some current COVID-19 antiviral treatments, such as Pfizer’s antiviral pill, Paxlovid. That drug has been shown to reduce the risk of severe COVID-19 by as much as 89 percent if taken within three days after the onset of symptoms.
Still, “particularly in resource-limited settings or for individuals without access to SARS-CoV-2 monoclonal antibody therapy or direct antivirals,” fluvoxamine might provide an easily accessible alternative, the study authors write.
The fact that the drug is widely available and with a large amount of safety data is another potential benefit since it was approved by the Food and Drug Administration (FDA) in 1994.
However, even with this meta-analysis in hand, experts say fluvoxamine
is likely to be a minor tool with which to battle the COVID-19
pandemic.
The researchers report that fluvoxamine treatment appeared to reduce the risk of severe COVID-19 by about 25 percent if given to people at high risk for COVID-19 early in the course of their infection.
That’s significantly less effective than some current COVID-19 antiviral treatments, such as Pfizer’s antiviral pill, Paxlovid. That drug has been shown to reduce the risk of severe COVID-19 by as much as 89 percent if taken within three days after the onset of symptoms.
Still, “particularly in resource-limited settings or for individuals without access to SARS-CoV-2 monoclonal antibody therapy or direct antivirals,” fluvoxamine might provide an easily accessible alternative, the study authors write.
The fact that the drug is widely available and with a large amount of safety data is another potential benefit since it was approved by the Food and Drug Administration (FDA) in 1994.
Many existing drugs like the ones in C19Early.com have been used to treat COVID and often initial reports show success. However, there's concern that these studies took place before the rise of the Omicron variant of COVID-19, which has rendered certain prior treatments ineffective, such as GlaxoSmithKline’s sotrovimab. That newfound inefficacy led to the FDA revoking its emergency use authorization for the drug.
Metformin, Ivermectin, Fluvoxamine Do Not Prevent Severe COVID-19 (August 2022)
For patients with COVID-19 infection, metformin, ivermectin, and fluvoxamine do not prevent the occurrence of hypoxemia, an emergency department visit, hospitalization, or death, according to a study published in the Aug. 18 issue of the New England Journal of Medicine.
Carolyn T. Bramante, M.D., M.P.H., from the University of Minnesota in
Minneapolis, and colleagues used a 2-by-3 factorial design to test the
effectiveness of metformin, ivermectin, and fluvoxamine in preventing
serious severe acute respiratory syndrome coronavirus 2 infection in
non-hospitalized adults enrolled within three days after a confirmed
diagnosis of infection and less than seven days after symptom onset.
Patients were aged 30 to 85 years, and
all had overweight or obesity. The primary analysis included 1,323
patients.
"None of the trial drugs resulted in a lower severity of symptoms than identically matched placebo," the authors write.
The fluvoxamine placebo tablets were donated by Apotex. The ivermectin placebo and active tablets were donated by Edenbridge. Two authors disclosed financial ties to Medtronic.
"None of the trial drugs resulted in a lower severity of symptoms than identically matched placebo," the authors write.
The fluvoxamine placebo tablets were donated by Apotex. The ivermectin placebo and active tablets were donated by Edenbridge. Two authors disclosed financial ties to Medtronic.
FDA Turns Down Fluvoxamine Emergency Use Authorization Request (May 2022)
The Food and Drug Administration denied an emergency use authorization for fluvoxamine as a SARS-CoV-2 antiviral. Fluvoxamine was proposed as a possible antiviral in 2021 due to its mechanisms of action for treating obsessive-compulsive disorder. These same mechanisms were suspected to inhibit SARS-CoV-2, leading to four trials testing the efficacy of the drug.In December 2021, Dr. David R Boulware requested an emergency use authorization for the outpatient treatment of adults testing positive for SARS-CoV-2 to prevent progression to severe symptoms based on early efficacy data from the fluvoxamine trials. The Food and Drug Administration denied his request, listing concerns such as insufficient data.
“There are effective therapeutics that are available. But not everyone has
access to them. Not everyone can tolerate them. Some people have
contraindications,” Boulware argued in response to the FDA rejection. “And if you go elsewhere in the world, low- and middle-income
countries, they have access to no therapeutics.”
Here we will discuss the FDA’s decision and reasoning.
The FDA’s main concern was the lack of conclusive evidence from four
trials that were below emergency use authorization standards. The largest
of the four trials, the TOGETHER trial, was a randomized, double-blind,
placebo-controlled trial of high-risk patients in Brazil. The primary
endpoints of the trial were (1) emergency room visits lasting greater than
six hours and (2) hospitalization due to progression of Covid-19.
The FDA found that the success of the trial was fueled by the six-hour threshold, which they found to be arbitrary. A patient remaining in the emergency room for 5.9 hours after taking fluvoxamine was considered a positive data point, whereas 6.1 hours was considered a negative. In the FDA’s words, “there are uncertainties about…whether the 6-hour timepoint represents a clinically meaningful threshold.”
The other three trials were found to be inconclusive as well. The FDA noted that the STOP COVID trial had several damaging design flaws, including a lack of randomization, a small sample size, and only a single testing center. The STOP COVID 2 trial and the COVID-OUT trial both failed to demonstrate a positive efficacy for fluvoxamine and were terminated early for futility.
While the TOGETHER trial did achieve a positive efficacy based on its
trial design, the FDA ultimately concluded that the four trials failed to
provide sufficient data to conclude that fluvoxamine may be an effective
treatment for non-hospitalized Covid-19 patients.
The FDA found that the success of the trial was fueled by the six-hour threshold, which they found to be arbitrary. A patient remaining in the emergency room for 5.9 hours after taking fluvoxamine was considered a positive data point, whereas 6.1 hours was considered a negative. In the FDA’s words, “there are uncertainties about…whether the 6-hour timepoint represents a clinically meaningful threshold.”
The other three trials were found to be inconclusive as well. The FDA noted that the STOP COVID trial had several damaging design flaws, including a lack of randomization, a small sample size, and only a single testing center. The STOP COVID 2 trial and the COVID-OUT trial both failed to demonstrate a positive efficacy for fluvoxamine and were terminated early for futility.
The FDA’s notice of emergency use rejection for fluvoxamine was
concluded with currently available and approved treatments for Covid-19.
These include Paxlovid and Bebtelovimab. We note that Molnupiravir is listed among these as well, but we
discourage the use of this drug due to concerns about mutagenesis and
cytotoxicity (R).
Fluvoxamine and Melatonin
Both inflammation and blood clots are known to be features of severe COVID-19. Meanwhile, fluvoxamine is also known to raise melatonin, which might also help (von Bahr et al. 2000).As of September 2022, there are more than 15 published clinical studies of melatonin for treatment and prevention in COVID-19 and the results are promising even when it's given as a late treatment. The 2 early treatment studies provide promising evidence that melatonin was associated with an average improvement of 78%.
If you take a melatonin supplement, be careful: Too much can cause daytime sleepiness. There is no federal RDA nor any formal advice on supplement dose ranges.
FLCCC (Front Line COVID-19 Critical Care) I-CARE Protocol
The Front Line COVID-19 Critical Care (FLCCC) Alliance was
initially formed as a working group during the early COVID-19
pandemic days in response to multiple early reports of COVID
patients with an inexplicably high need for prolonged mechanical
ventilation and an excessive death rate.
There are many COVID-19 treatment protocols out there on the internet. We have reviewed many protocols and believe the FLCCC I-CARE protocol is one of the practical and effective protocols to follow.
The Front Line COVID-19 Critical Care Alliance has also developed other protocols aimed at prevention, long-haul COVID treatment, post-vaccine recovery and hospital treatment.
To find a list of physicians who follow the protocols and provide in-office and telehealth services: List of Doctors that will prescribe FLCCC protocols.
To find a list of physicians who follow the protocols and provide in-office and telehealth services: List of Doctors that will prescribe FLCCC protocols.
To find a list of pharmacist: List of Pharmacies that will fill FLCCC doctors' prescriptions.
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