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

Jolyon Attwooll

21/02/2022 4:50:26 PM

The drug’s use on mild-to-moderate COVID-19 patients does not stop disease progression, a newly published clinical trial suggests.

ivermectin packet
The use of ivermectin since the pandemic began has proved contentious. Image: AAP Photos.

The use of ivermectin to treat patients with mild-to-moderate COVID-19 does not prevent the onset of severe disease, the researchers behind a randomised clinical trial have concluded.
The results of the study appeared in a peer-reviewed article published this month on the Jama Network, an open access medical journal overseen by the American Medical Association.
Four hundred and ninety people aged over 50 were recruited to the Malaysia-based trial, which took place across 20 public hospitals and a COVID-19 quarantine facility between 31 May and 25 October last year.
The main outcome measured by the trial was the onset of severe disease, which was defined as the requirement for additional oxygen to keep the patients’ oxygen saturation at 95% or higher.
Of the 241 people in the ivermectin group, 52 (21.6%) went on to develop severe disease. There were 43 patients of the 249 (17.3%) in the control group who went on to have severe disease.
The researchers conclude that ivermectin use did not provide protection against severe disease among the cohort.
‘In this randomised clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease,’ the paper reads.
‘The study findings do not support the use of ivermectin for patients with COVID-19.’
Patients were enrolled within a week of the onset of COVID-19 symptoms, and all of them had laboratory-confirmed COVID-19 as well as at least one comorbidity.
Likewise, all trial participants had mild-to-moderate disease when they were enrolled, with asymptomatic patients excluded from the trial. They were then randomised to either receive standard care and a five-day course of ivermectin taken orally over five days, or standard care alone. 
The daily ivermectin doses were set 0.4 mg per kilogram of body weight, the paper states.
Authors describe standard care as consisting of ‘symptomatic therapy 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 was recorded in 44 patients, with 33 of them among the ivermectin group. Diarrhoea was the most common. Five of the adverse events were classified as serious, including four among the ivermectin group.
‘The notably 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 study limitations, including that the trial’s open-label design could lead to under-reporting of adverse events in the control group, and overestimates of drug effects among the ivermectin group.
The authors also said the older age of the study cohort could limit its relevance.
‘The generalisability of our findings may be limited by the older study population, although younger and healthier individuals with low risk of severe disease are less likely to benefit from specific COVID-19 treatments,’ the paper reads.
Several other trials investigating the use of ivermectin as a COVID-19 treatment are ongoing, but the results of a previous randomised clinical trial in Argentina also found no significant effect of ivermectin hospitalisation rates for patients with COVID-19.
Researchers from one trial at the University of Oxford told Reuters they did not wish to comment on the results of the Malaysian trial until they were ready to report the outcomes of their own analysis.
The results of another clinical trial conducted by Monash University into the use of ivermectin as an antiviral against COVID-19 are also yet to be published.
The off-label use of ivermectin, a cheap and widely available drug typically used as an anti-parasite treatment, has proved contentious.
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 raised about methods used by studies that have promoted ivermectin as an effective COVID-19 treatment.
In March last year, the World Health Organisation advised that it should only be used to treat COVID-19 in clinical trials, a stance also taken by Australia’s National COVID-19 Clinical Evidence Taskforce.
The treatment has gained traction due in part to the support of high-profile figures without any medical background, including US-based podcaster Joe Rogan, and politician Craig Kelly in Australia.
In September last year, the Therapeutic Goods Administration (TGA) restricted the prescribing of ivermectin, saying that doses advocated for in ‘unreliable social media posts’ were ‘significantly higher’ than those approved for parasite treatment.
‘These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures and coma,’ the TGA said.
It also said ivermectin prescriptions had more than tripled at the time and had led to national and local shortages for the drug’s approved use for scabies and parasite infections.
Last August, imports of the drug were reportedly 10 times higher than previous levels, while pharmacists also reported a rise in customers not disclosing the reason for an ivermectin prescription.
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