IVERMECTIN is not recommended for Covid-19 treatment as it does not reduce the risk of severe illness from the virus, health director-general Dr Noor Hisham Abdullah said in announcing the findings of the clinical trials on the drug.

The ivermectin study (I-TECH) by the Health Ministry involved 500 patients hospitalised for categories 2 and 3 of Covid-19.

Noor Hisham said the the multi-centre open-label randomised controlled trial evaluated a five-day course of ivermectin (0.4mg/kg/day) plus standard of care (IVM group), compared to standard of care (SOC group) according to the ministry’s guidelines at 20 government hospitals and MAEPS 2.0 quarantine and Covid-19 treatment centres.

The trial was conducted by infectious disease physicians and clinicians who were actively involved in Covid-19 management, in collaboration with the Institute for Clinical Research (ICR) and the National Institute of Health (NIH).

“Based on the outcomes of the I-TECH study, ivermectin cannot be recommended for inclusion in the current Covid-19 treatment guidelines as it does not reduce risk of severe illness from the virus.

“MOH continues with prior advice that ivermectin only be used within clinical trials settings with monitoring,” Noor Hisham said.

He said I-TECH’s study is also consistent with other large scale studies such as the IVERCOR-Covid19 from Argentina and from Brazil, which are not supportive of the routine usage of ivermectin in clinical practice.

“It is hoped that the findings of this local study will inform medical practitioners in Malaysia and also to the public, who often ask about the effectiveness of ivermectin in the clinical practice of Covid-19 treatment.

“Until further supportive evidence becomes available, practitioners are cautioned not to recommend ivermectin, including sharing illegal advertising or sale of the drug for Covid-19 treatment,” he said.

Noor Hisham said the study team is also planning to submit the data for publication in a peer-reviewed journal, which will help to provide additional research information for ivermectin studies including meta-analysis.

Study findings

Noor Hisham said the objective of the study is to determine whether ivermectin administered during the first week of illness prevented deterioration to categories 4 and 5 of Covid-19 among hospitalised patients aged 50 years and above who had at least one pre-existing health condition.

ICR director Dr Kalaiarasu M. Peariasamy said the I-TECH findings showed that patients in the IVM group compared to the SOC group had similar rates of progression to severe Covid-19 disease at 21.2% and 17.3% respectively.

“For the same primary outcome, the mean time to progression was 3.0 days for the IVM group compared to 2.9 days for the SOC group, but the difference was not statistically significant: p=0.68,” he said.

The study initiated by MOH obtained Medical Research and Ethics Committee approval on May 25 and was registered in ClinicalTrials.gov on May 31, to make the study’s findings available to the public.

Of the 500 subjects enrolled in the trial, four were excluded for not meeting study criteria and six withdrew after expressing concerns about the drug’s side effects. The last subject was recruited on October 9 and the follow-up ended on October 25.

Principal investigator of the I-TECH study, Dr Steven Lim Chee Loon, who is an infectious disease specialist at Raja Permaisuri Bainun Hospital in Ipoh, said there were no significant differences found in terms of intensive care unit admissions, mechanical ventilation, symptom recovery, blood parameters and chest X-ray resolution in both groups.

He said the odds of complete symptom recovery by the fifth day of enrolment between IVM and SOC groups were very similar and not statistically significant.

Safety analysis also showed that three times more adverse events were reported in the IVM group versus the SOC group, which most commonly was diarrhoea.

Meanwhile, there was a trend of 28-day mortality reduction by IVM with standard of care, but it was not statistically significant.

Professor Lai Nai Ming and Associate Professor Karuthan Chinna of Taylor’s School of Medicine, who provided independent statistical analysis, said the I-TECH study could not confirm whether ivermectin administered in hospital led to fewer deaths in 28 days compared to standard care.

This was inconclusive due to the small number of deaths – 13/490 – which provided limited evaluation of the result.

Ivermectin has been the topic of conversation among advocates, including politicians who pushed for the use of the anti-parasitic drug in Covid-19 treatment, although its effectiveness had yet to be proven. – November 3, 2021.