Ivermectin ‘does not prevent severe COVID-19’: study

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Using the drug on mild to moderate COVID-19 patients does not halt disease progression, a recently published clinical trial suggests.

The use of ivermectin since the start of the pandemic has proven controversial. Image: AAP Photos.


Using ivermectin to treat patients with mild to moderate COVID-19 does not prevent the onset of severe disease, researchers behind a randomized clinical trial have concluded.


The results of the study have been published in a peer-reviewed article published this month on the Jama Networkan open access medical journal overseen by the American Medical Association.


Four hundred and ninety people aged over 50 were recruited for the Malaysia-based trial, which took place in 20 public hospitals and one COVID-19 quarantine facility between May 31 and October 25. from last year.


The primary outcome measured by the trial was the onset of severe disease, defined as the need for supplemental oxygen to maintain patients’ oxygen saturation at 95% or higher.


Of the 241 people in the ivermectin group, 52 (21.6%) developed severe disease. There were 43 patients out of 249 (17.3%) in the control group who continued to have severe disease.


The researchers conclude that the use of ivermectin did not provide protection against severe disease among the cohort.


“In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment early in the disease did not prevent progression to severe disease,” the paper says.


“The study results do not support the use of ivermectin for patients with COVID-19.”


Patients were recruited within a week of onset of COVID-19 symptoms, and all had laboratory-confirmed COVID-19 as well as at least one comorbidity.


Similarly, all trial participants had mild to moderate disease at enrollment, with asymptomatic patients excluded from the trial. They were then randomized to receive either standard care and a five-day course of ivermectin taken by mouth for five days, or standard care alone.


Daily doses of ivermectin have been set at 0.4 mg per kilogram of body weight, the document states.


The authors describe standard care as consisting of “symptomatic treatment and monitoring for signs of early deterioration” based on clinical findings, laboratory test results, and chest imaging.


There were 13 deaths among the entire cohort, or 2.7% of the entire group.


A total of 55 adverse events were recorded in 44 patients, including 33 in the ivermectin group. Diarrhea was the most common. Five of the adverse events were classified as serious, including four in the ivermectin group.


“The significantly higher incidence of [adverse events] in the ivermectin group raises concerns about the use of this drug outside of trial settings and without medical supervision,” the authors wrote.


However, the researchers also acknowledged several limitations of the study, including that the open-label design of the trial could lead to underreporting of adverse events in the control group and overestimation of drug effects in the ivermectin group. .


The authors also said that the older age of the study cohort might limit its relevance.


“Generalizability of our findings may be limited by the older study population, although younger, healthier individuals at low risk of severe disease are less likely to benefit from specific COVID-19 treatments,” the report says. document.


Several other trials investigating the use of ivermectin as a treatment for COVID-19 are underway, but the results of a previous randomized clinical trial in Argentina also found no significant effect of ivermectin hospitalization rates for patients with COVID-19.


Researchers in a trial at Oxford University Recount Reuters they declined to comment on the results of the Malaysian trial until they were ready to report the results of their own analysis.


The results of another clinical trial conducted by Monash University on the use of ivermectin as an antiviral against COVID-19 are also to be published.


The off-label use of ivermectin, a cheap and widely available drug typically used as an antiparasitic treatment, has proven controversial.


In the early stages of the pandemic, the drug was identified as a potential treatment for COVID-19 by Melbourne scientists due to its ability to kill the SARS-CoV-2 virus in cells in the laboratory.


However, its potential for use has not been proven, with widespread concerns about the methods used by studies that have promoted ivermectin as an effective treatment for COVID-19.


In March of last year, the world health organization said it should only be used to treat COVID-19 in clinical trials, a position also taken by Australia’s National COVID-19 Clinical Evidence Task Force.


The treatment has gained traction in part thanks to the support of high-profile figures without any medical training, including US-based podcaster Joe Rogan and politician Craig Kelly in Australia.


In September last year, the Therapeutic Goods Administration (TGA) restricted the prescription of ivermectin, saying the doses advocated in “unreliable social media posts” were “significantly higher” than those approved for the drug. parasite treatment.


“These higher doses may be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as lightheadedness, seizures, and coma,” the TGA said.


He also said ivermectin prescriptions more than tripled at the time and led to national and local shortages for the drug’s approved use for scabies and parasitic infections.


Last August, imports of the drug were reported to be 10 times higher than previous levels, while pharmacists also reported an increase in customers not disclosing the reason for an ivermectin prescription.



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