Adults with mild to moderate COVID-19 treated with fluvoxamine (Luvox) 50 mg twice daily for 10 days did not do so faster than those taking placebo, the randomized controlled trial of the ACTIV-6 platform showed.
Among nearly 1,300 adult outpatients, sustained symptom-free recovery for at least 3 consecutive days took a median of 12 days for those treated with fluvoxamine compared with 13 days for those treated with placebo (HR 0. 96, 95% CI 0 . 86-1. 06). , p = 0. 21).
The secondary end results of a compound that required hospitalization, emergency care or emergency room care were also similar among treatment and control teams (26 vs. 23 cases, 3. 9% vs. 3. 8%), found Susanna Naggie, MD, of Duke Durham University School of Medicine, North Carolina. and colleagues.
“These effects do not affect the use of fluvoxamine at this dose and duration in patients with mild to moderate COVID-19,” the researchers reported in JAMA. However, “there are many conflicting trials on the use of fluvoxamine, and some of the differences would possibly be attributable to dose. “
They cited the TOGETHER trial, in which treating mild COVID-19 in high-risk patients with a dose of 100 mg fluvoxamine twice, twice the amount given to ACTIV-6 participants, reduced hospitalizations. However, “tolerability is known as a possible restriction for the use of this dose of fluvoxamine,” Naggie and colleagues noted.
But despite early trials suggesting benefits for hospitalization from any cause, STOP COVID 2 and COVID-OUT have not shown those benefits.
Preliminary effects from the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) trial, presented at IDWeek in October, showed no positive benefits for repurposed drugs, adding ivermectin, metformin or fluvoxamine for the treatment of COVID-19.
Precisely when those trials were conducted, the major variants circulating at the time, the threat of reference in the populations examined, and the prestige of vaccination likely influenced the interpretation of those and earlier trials, according to an editorial by Adarsh Bhimraj, MD, Houston Methodist Hospital and Jason C. Gallagher, PharmD, of Temple University. Philadelphia.
Fluvoxamine, “one of the most attractive healing candidates” known in the “hasty investigation of drugs approved for the reuse of SARS-CoV-2,” they noted, because this generic and affordable selective serotonin reuptake inhibitor possesses anti-SARS-CoV-2, anti-inflammatory and antiplatelet activity.
While the difference between trials in dosing regimens may have been only one thing in the results of other trials, the editorialists concluded that “the totality of the evidence for fluvoxamine does not support its current use for the treatment of mild to moderate COVID-19. “
In May, the FDA rejected an application for emergency use authorization for the use of fluvoxamine to treat COVID-19, calling the knowledge insufficient.
While thanking the fluvoxamine test researchers “for their patience in investigating the imaginable role of this affordable therapy,” Bhimraj and Gallagher wrote that the same is needed for other drugs, such as legal antivirals. Immunonaïve populations and the most problematic variants of SARS-CoV-2 require further examination to delineate their role in the existing COVID-19 landscape. “
The fluvoxamine ACTIV-6 trial included 1288 elderly outpatients aged 30 years or older (median 47 to 48 years) who showed SARS-CoV-2 infection for 10 days or less and two or more COVID-19 symptoms for 7 days or less.
The population examined was similarly matched with controls. About two-thirds of participants had received two or more doses of the COVID-19 vaccine; Women accounted for 57 percent of the population examined. A total of 2. 3 percent of treatment and control teams experienced severe symptoms during the first day.
Remedy and control teams reported similar rates of high blood pressure (23. 3% vs. 25. 7%), asthma (13. 5% vs. 12. 8%), diabetes (9% vs. 9. 5%), and central disease (3. 5% vs. 5. 1%). %).
One user was hospitalized in the organization of the remedy and two in the organization of the placebo. No deaths were reported in either organization during the 28-day follow-up.
The study was limited to the few clinical events and the inability to assess clinical outcomes. In addition, the median time to start the study drug was five days after symptom onset, “which is at the upper limit of study initiation. “started with antiviral drugs,” the researchers noted.
Ingrid Hein is infectious disease editor for MedPage Today. She has been a medical journalist for more than a decade. Follow
ACTIV-6 is supported by the National Center for the Advancement of Translational Sciences, the Office of the Under Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, Vanderbilt University Medical Center, and the REDCap infrastructure.
Naggie reported grants and money from Gilead, AbbVie, Pardes Biosciences and Personal Health Insights; consulting and inventory functions with Vir Biotechnology and Silverback Therapeutics; and recommendation for Bristol Myers Squibb and PRA. Study co-authors revealed relationships with and/or various entities.
Bhimraj reported private fees to the Institute for Clinical and Economic Review and chaired the Infectious Diseases Society of America’s rules on the treatment and management of COVID-19 patients. Gallagher pointed to subsidies and private rates from Merck and Shionogi.