Fluvoxamine and COVID-19: Here’s How the OCD Drug Might Help Prevent COVID-19 Infections From Getting Worse (May 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). But now, researchers are taking a closer look at how the medication could be an important treatment to prevent patients who test positive for COVID-19 from getting seriously ill with the infection.
 
Fluvoxamine and COVID-19

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 nonhospitalized Covid-19 patients.

The FDA’s notice of emergency use rejection for fluvoxamine was concluded with currently available and approved treatments for Covid-19. These include Paxlovid, Remdesivir, Bebtelovimab, and convalescent plasma. 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).

FLCCC (Front Line COVID-19 Critical Care) I-MASK Protocol


FLCCC Putting Patients First

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. 

Based on rapidly emerging clinical trials evidence, the FLCCC team has developed the I-MASK+ protocol for prophylaxis and at home treatment of early stage COVID-19. 

Fluvoxamine was added to the latest FLCCC I-MASK+ early outpatient protocol as one of the second line agents for early treatment. Check out the summary of evidence on Fluvoxamine versus COVID-19 from c19fluvoxamine.com (constantly updated).

For updated prevention and early outpatient protocol  for COVID-19 positive, please check out FLCCC I-MASK+ protocolFor post-covid or long covid syndrome, check out FLCCC I-Recover Post-COVID Protocol

Note about TOGETHER trial results for fluvoxamine and ivermectin

Why did Ivermectin seem to fail and Fluvoxamine not do so well? 

According to Steve Kirsch:

Ivermectin was dosed for 3 days; fluvoxamine for 10 days.

We don't think the trial was gamed at all. I think this was a legit result.

We know the Principal Investigator Edward Mills and believe he is totally honest and we have no reason not to believe the results he obtained. But we also believe other researchers as well.

So the question everyone has is how could these drugs do so well in other studies?

The answer: the variant was different. P1 is the variant in Brazil and makes Delta look like a walk in the park. If you do not treat P1, instantly upon symptoms, you will see big failures.

Had fluvoxamine been given on Day 0 instead of Day 4, there would have been a dramatically different result.

Had ivermectin been dosed at 0.6mg/day for 14 days starting on Day 0 (the first day of symptoms), there would have been a dramatically different result.

The more aggressive the variant, the earlier and harder you have to treat it.

Ivermectin likely failed for these four reasons:
  • too little a dose
  • started too late
  • not continued for long enough
  • many patients may have already been taking ivermectin
Those are the 3 biggest reasons. The healthcare systems need to encourage people to have the meds in the cabinet for immediate use. Nobody does that. That's why we have a problem.

Also, you can't treat Delta and P1 in the hospital... it is much much tougher there. It's like a fire department arriving when the entire building is in flames. 

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.

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.

Fluvoxamine vs Other Options

The recommendations below are based on both scientific studies and the experience of clinicians in treating COVID-19.

There are many drugs and supplements that have varying levels of positive effectiveness against the virus including inhaled budesonide, bromhexine, vitamin D, and HCQ. All of these have the greatest value when started as early as possible. There is no benefit to waiting. In general, these drugs (and supplements) are safe with very low side-effect profiles. Your doctor may recommend adding one or more of these drugs at the start of treatment in addition to ivermectin and fluvoxamine. For patients with severe or worsening respiratory symptoms, 4-8 mg cyproheptadine 3-4 times a day has been shown to be very helpful as well.

The combination of ivermectin and fluvoxamine is extremely effective when used ASAP. Two of the most effective drugs to treat Covid early are ivermectin and fluvoxamine. Both drugs should be started together at the same time. If you are treated within 48 hours of first symptoms, research shows that ivermectin should be given at a dose of 0.4mg/kg for a minimum of 5 days or until symptoms resolve, whichever is later. Fluvoxamine should be given as 50 mg twice a day for 14 days. 

The website www.c19early.com shows that these are the two approved drugs which individually have shown to be the most effective against Covid in two or more studies. Used together, these drugs have no common adverse interactions and have complementary mechanisms of action. For instance, fluvoxamine is a potent anti-inflammatory and, because it is able to penetrate the blood-brain barrier, it is effective in preventing inflammation in your brain. Unlike systemic steroids, fluvoxamine does not impair your ability to fight the virus so it can be used immediately. The fluvoxamine dose effective against Covid is just one third of the FDA-approved dose so side effects are very rare and minimal. I am not aware of anyone who started both drugs within 48 hours of first symptoms who didn’t have a rapid recovery. The best method to catch the virus early is to test regularly, and start treatment upon a positive test. This is because the PCR test can detect Covid before symptoms start.

If fluvoxamine isn’t available, fluoxetine is a viable substitute (Scientific Reports 2021). All the data we’ve seen shows that if you can’t get fluvoxamine, using 30mg once a day of fluoxetine (Prozac) is equally effective (equivalent to 50mg twice a day of fluvoxamine).

Alternate Treatments 

For a list of COVID-19 early treatment studies, check out c19early.com (constantly updated).

Find a Doctor who will Prescribe Fluvoxamine in US

MULTIPLE STATES (Telemedicine or online consultation)

CityHealth Locations:

13690 E 14th St., Suite 100, San Leandro, CA 94578
(510) 984-2489

1300 Clay St St., Suite 165, Oakland, CA 94612
(510) 984-2489

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.


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