THE Ministry of Health (MOH) has initiated randomised clinical trial on the anti-viral drug Ivermectin, director-general of health Dr Noor Hisham Abdullah said.

His statement comes in the wake of unproven claims that the drug was effective in treating Covid-19.

The World Health Organisation (WHO) has previously recommended the use of the drug only in Covid-19 clinical trials.

“The MOH has initiated a randomised clinical trial to repurpose Ivermectin and evaluate its efficacy and safety in high-risk Covid-19 patients,” Noor Hisham said in a statement.

He said the trial will involve 500 Covid-19 patients from 12 government hospitals.

The ministry, he said, is hoping to have a correct perspective on the clinical effectiveness of Ivermectin through the study.

“Although Malaysia’s risk for Covid-19 may be heightened at the moment, we must keep in mind that in all circumstances, we need to take steps necessary to figure out what really works,” he said.

“Without the benefit of evidence from well-designed clinical trials, MOH is unable to endorse Ivermectin to prevent or treat Covid-19 illness. Science remains the best weapon against the SARS-Cov-2 virus, not circumstantial hype,” he added.

Ivermectin is an anti-parasitic drug that is mostly used in veterinary medicine, particularly in treatment of worm infestations.

“In April 2020, researchers using laboratory methods showed that Ivermectin can also inhibit the replication of SARS-CoV-2, the novel virus that causes Covid-19 illness. Since then, many authors relying on findings from small studies and case series have suggested the potential use of Ivermectin against Covid-19,” he said.

Noor Hisham noted that the recommendation for the “off-label” use of Ivermectin in Covid-19 treatment has been controversial since the beginning.

He said many studies done using the drug had limitations including small sample sizes, non-controlled study designs or the drug being used as add-on treatment.

“Therefore, this had confounded the effect of Ivermectin, if any. In January 2021, a placebo-controlled randomised trial involving 24 non-severe Covid-19 patients did not manage to show reduction in the proportion of PCR positive patients at Day 7 post-Ivermectin 400 mcg/kg single oral dose treatment,” he said.

“The authors of the pilot study, published in e-Clinical Medicine (Lancet), opinionated that larger trials may be needed to understand the effects of Ivermectin. In March this year, the Journal of American Medical Association published a randomised-controlled trial involving 476 adults with mild Covid-19 disease given a 5-day course of Ivermectin.

“The results showed that there was no significant improvement in Covid-19 symptoms resolution time. While Ivermectin may have some anti-viral and anti-inflammatory effects, the evidence remains inconclusive,” he added.

Noor Hisham said regulatory bodies including the US Food and Drug Authority and the European Medicines Agency have concluded that there was insufficient evidence to support the use of Ivermectin as treatment of Covid-19, after evaluating these studies.

“WHO also issued guidelines against the routine use of Ivermectin in the treatment of Covid-19 except in clinical trial settings,” he said.

However, he said several NGOs and those who want the drug repurposed against Covid-19 are propagating the drug as being a miracle drug, regardless of the conclusion of health authorities.

“Recently, the Coalition on Integrity of Vaccines & Drugs against Covid-19 (CIVDAC) Malaysia, surmised that no one would die from Covid-19 if only Ivermectin is given from the onset of one’s illness.”

“Specifically, CIVDAC cites scientific proof on the utility of Ivermectin as recommended by some experts from US-based Front Line Covid-19 Critical Care (FLCCC),” he said.

However, he said the synthesis of the evidence includes inferences only from preliminary reports of work without peer review. – May 16, 2021.