A new peer-reviewed study found that regular use of ivermectin reduced the risk of dying from COVID-19 by 92%.
The large study was conducted by Flávio A. Cadegiani, MD, MSc, PhD. Cadegiani is a board-certified endocrinologist with a master’s degree and doctorate degree in clinical endocrinology.
The peer-reviewed study was published on Wednesday by the online medical journal Cureus. The study was conducted on a strictly controlled population of 88,012 people from the city of Itajaí in Brazil.
Individuals who used ivermectin as prophylaxis or took the medication before being infected by COVID experienced significant reductions in death and hospitalization.
According to the study, those who took ivermectin regularly had a 92% reduction in their COVID death risk compared to non-users and 84% less than irregular users.
“The hospitalization rate was reduced by 100% in regular users compared to both irregular users and non-users,” the study stated.
The impressive reduction for regular ivermectin users was evident despite the regular users being at a higher risk for COVID deaths. The regular users were older and had a higher prevalence of type 2 diabetes and hypertension than irregular and non-users.
Irregular users of ivermectin had a 37% lower mortality rate reduction than non-users.
The study defined regular users as those who used more than 30 tablets of ivermectin over five months. The dosage of ivermectin was determined by body weight, but “most of the population used between two and three tablets daily for two days, every 15 days.”
“Non-use of ivermectin was associated with a 12.5-fold increase in mortality rate and a seven-fold increased risk of dying from COVID-19 compared to the regular use of ivermectin,” the study read. “This dose-response efficacy reinforces the prophylactic effects of ivermectin against COVID-19.”
Cadegiani believes the study showed a “dose-response effect” – which means that increasing levels of ivermectin decreased the risk of hospitalization and death from COVID-19.
Cadegiani wrote on Twitter, “An observational study with the size and level of analysis as ours is hardly achieved and infeasible to be conducted as a randomised clinical trial. Conclusions are hard to be refuted. Data is data, regardless of your beliefs.”
UVA Health joins nationwide study examining ivermectin as COVID-19 treatment
The University of Virginia Health System has joined a nationwide clinical study to evaluate ivermectin and fluvoxamine as possible treatments for mild-to-moderate COVID-19.
The study, called ACTIV-6, is funded by the National Institutes of Health and seeks to determine whether cheap, widely available, and FDA-approved drugs can be repurposed to treat the coronavirus. Researchers are testing several medications including ivermectin, an anti-parasitic drug that some claim is an effective early treatment or prophylaxis for COVID-19.
The FDA has repeatedly warned against using ivermectin as a COVID-19 therapeutic, along with the World Health Organization, the European Union’s drug regulators, and the drug’s manufacturer Merck. But some doctors in the U.S. and medical freedom advocates have demanded a right to try ivermectin and other unproven drugs to treat COVID-19, claiming some coronavirus patients have shown improvement after taking those off-label medications.
Patrick E. H. Jackson, MD, the principal investigator for the ACTIV-6 clinical trial at UVA Health, is hopeful that the study will provide “conclusive answers about drugs like ivermectin and fluvoxamine for the treatment of mild-moderate COVID-19.”
“While the monoclonal antibodies and nirmatrelvir-ritonavir (Paxlovid) are wonderful to have, there is a clear need for more (and more broadly available) drugs to help patients around the world,” Jackson told TheBlaze.
He explained that the ACTIV6 study includes participants who have mild to moderate COVID-19 symptoms and who are within seven days of the onset of symptoms. The study is a double-blind placebo controlled trial. COVID-19 Patients will be given a random drug or a placebo and researchers will collect information from them on the duration of their symptoms, as well as whether they are required to go to the hospital.
Most of the participants will be at home and will complete questionnaires to report their condition.
Previous studies examining ivermectin as a COVID-19 treatment have failed to prove it is an effective treatment. While laboratory studies show that ivermectin appears to have an anti-viral effect against COVID-19 and some early clinical trials seemed to support its use as a COVID-19 treatment, doctors and public health experts have identified serious errors in methodology in many of those studies.
An investigative report by the BBC found that more than a third of 26 major trials with ivermectin against COVID-19 had “serious errors or signs of potential fraud,” and that the remaining studies did not show it was effective as a treatment for COVID.
More widely accepted studies do not support the use of ivermectin for patients with COVID-19.
Some proponents of ivermectin as a COVID-19 treatment have championed a more recent peer-reviewed study that concluded “regular use of ivermectin as a prophylactic agent was associated with significantly reduced COVID-19 infection, hospitalization, and mortality rates,” based on an observational study of 159,561 residents ages 18 and over in Itajaí, Brazil.
A group called the Front Line COVID-19 Critical Care Alliance touted the study as the “world’s largest study of ivermectin.”
According to the study’s authors, between July 7, 2020, and Dec. 2, 2020, 113,845 participants of a citywide program opted to take ivermectin while 45,716 did not. Researchers found that 3.7% of the group that took ivermectin tested positive for coronavirus while 6.6% of those that didn’t take ivermectin tested positive.
The study’s authors claimed that after adjusting for variables, there was a 67% reduction in COVID-19 hospitalizations and a 70% reduction in the mortality rate for ivermectin users.
Though those results appear to be good news, experts that did not participate in the study criticized its methodology.
Dr. Jackson noted that the Brazil study was a non-randomized observational study. “Such studies can really only ever be hypothesis generating – that is they can raise interesting questions to be studied further, but can’t show a causal relationship between an intervention and an outcome (in that case, ivermectin and COVID infection/hospitalization/mortality),” he said.
“I’m very hopeful that trials like ACTIV6 and COVID-OUT will give us conclusive answers about drugs like ivermectin and fluvoxamine for the treatment of mild-moderate COVID-19,” he added.
Doctors take on Biden administration for right to try ivermectin as COVID-19 treatment
A group of doctors have filed a lawsuit against the Food and Drug Administration and the Department of Health and Human Services over what they claim is an “unlawful” prohibition on the use of ivermectin to treat COVID-19.
Attorneys for Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik argued in a June 2 court filing that the FDA did not have the authority to direct public health professionals and patients to stop using ivermectin as a COVID-19 treatment. Their lawsuit against HHS Secretary Xavier Becerra and FDA Commissioner Robert M. Califf accuses the government of illegally banning an approved drug from “off-label” use.
“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship,” the complaint states. “Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”
The lawsuit cites numerous examples of what the doctors call “formal, unequivocal, and conclusory actions” by the FDA to “prohibit or otherwise interfere with the use of ivermectin to treat COVID-19.”
The FDA also warned that some individuals who have self-medicated with ivermectin to treat COVID needed medical attention, including hospitalization, because they overdosed by taking a version of the drug intended for livestock. The lawsuit also cited a tweet from the FDA that referenced these reports by saying, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
Numerous studies have failed to identify ivermectin, a drug that’s approved for treating parasites, as an effective treatment for COVID-19.
Most recently, a large clinical trial by researchers at Duke University concluded that iveremctin did not reduce the length of COVID-19 symptoms or hospitalizations for patients. With more than 1,500 people with mild or moderate COVID-19 symptoms enrolled in the study, it was the largest randomized trial conducted to date — though it has yet to be peer-reviewed.
While the doctors dispute these findings, the lawsuit emphasizes the court is not being asked to determine whether ivermectin is an effective COVID-19 treatment.
The case “is about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process,” the complaint states.
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