WASHINGTON -- There were nary differences successful alleviation from mild-to-moderate COVID-19 symptoms for patients connected ivermectin versus placebo, according to the ongoing ACTIV-6 trial.
Among >1,000 vaccinated and unvaccinated patients, the median clip to betterment was 12 days for those successful the ivermectin radical and 13 days successful the placebo group, reported Matthew McCarthy, MD, of Weill Cornell Medicine successful New York City, astatine IDWeek.
As a result, the hazard ratio for betterment successful clip to betterment was 1.07 (95% credible interval 0.96-1.17, posterior P=0.91), McCarthy and colleagues stated successful JAMA, wherever the results were simultaneously published.
He noted that the existent proceedings was conducted during Delta and Omicron variant surges successful the state (June 23, 2021 done Feb. 4, 2022).
McCarthy said during the presumption that attraction with 2 different repurposed agents -- the antidepressant fluvoxamine (Luvox) and the inhaled steroid fluticasone -- did not connection importantly amended outcomes than placebo. "We observed nary important differences successful alleviation of mild-to-moderate symptoms betwixt participants taking ivermectin, fluticasone, oregon fluvoxamine and participants taking placebo. There was nary quality observed successful the fig of hospitalizations oregon deaths betwixt patients taking ivermectin, fluticasone, oregon fluvoxamine and participants taking placebo. There were nary information concerns identified successful immoderate arm," helium stated.
"These results are accordant with what we person seen successful different trials with these agents," said IDWeek league co-moderator Adarsh Bhimraj, MD, of Houston Methodist.
"This is simply a immense level trial," helium told MedPage Today. "It's spot is successful the numbers of patients included, and that it was conducted aboriginal successful the pandemic which is much applicable to america now, and it is besides concordant with different studies."
Bhimraj stated that "there were nary surprises with these results of ACTIV-6, which...is good," adding that studies showing which treatments bash not enactment person arsenic overmuch worth arsenic those that show which treatments bash work.
He besides pointed retired that "across each these trials with these antithetic agents, the information signals are not that bad."
McCarthy's radical reported that determination were 10 hospitalizations oregon deaths successful the ivermectin radical and 9 successful the placebo radical (1.2% vs 1.2%, HR 1.1, 95% CrI 0.4-2.6). The astir communal superior adverse events were COVID-19 pneumonia with 5 cases successful the ivermectin radical and 7 successful the placebo group, on with venous thromboembolism (one and 5 cases, respectively). There was 1 decease successful the ivermectin group.
For the ivermectin limb of ACTIV-6, 814 radical were connected ivermectin (400 μ6/kg) and 774 radical were connected placebo, regular for 3 days. Less than fractional reported receiving astatine slightest 2 doses of a SARS-CoV-2 vaccine. Median diligent property was 48, 57% were women, and astir 80% were white. There were 656 patients successful the fluticasone limb and 621 connected placebo. About a 3rd of the patients had not had immoderate COVID vaccine. Median property was astir 46, 63% were women, and astir 80% were white. Finally, determination were 674 patients connected fluvoxamine and 624 patients connected placebo. About two-thirds had received astatine slightest 2 doses of the vaccine. They had a median property of 48 years, 58% were women, and astir 80% were white.
McCarthy and colleagues acknowledged that "the inclusion criteria allow[s] for a wide survey population, this survey failed to execute the level of practice desired for underrepresented populations successful presumption of radical and taste diversity," which was a survey limitation.
Still, they concluded that the "findings bash not enactment the usage of ivermectin successful patients with mild to mean COVID-19...this survey adds to the increasing grounds that determination is not a clinically applicable attraction effect of ivermectin astatine this dose and duration."
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Ed Susman is simply a freelance aesculapian writer based successful Fort Pierce, Florida, USA.
Disclosures
ACTIV-6 is funded by the National Center for Advancing Translational Sciences (NCATS), and supported by the Vanderbilt University Medical Center Recruitment Innovation Core, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Vanderbilt University Medical Center Clinical and Translational Science Award/NCATS, and REDCap infrastructure.
McCarthy disclosed nary relationships with industry. Co-authors disclosed relationships with, and/or enactment from, aggregate entities including NCATS.