Health D-G: Ministry cannot endorse Ivermectin to treat Covid-19 yet, clinical trial with 500 patients initiated

·3-min read
Health Director-General Tan Sri Dr Noor Hisham Abdullah speaks during a press conference in Putrajaya on November 4, 2020. — Picture by Shafwan Zaidon
Health Director-General Tan Sri Dr Noor Hisham Abdullah speaks during a press conference in Putrajaya on November 4, 2020. — Picture by Shafwan Zaidon

KUALA LUMPUR, May 16 — Health director-general Tan Sri Dr Noor Hisham Abdullah today said that the Ministry of Health (MoH) is unable to endorse the use of Ivermectin as an efficient drug to treat Covid-19 patients, as more evidence on its efficacy is needed.

In a statement this evening, he said that the MoH has also initiated a randomised clinical trial to repurpose Ivermectin and evaluate its efficacy and safety in high-risk Covid-19 patients.

The trial, he said, will enrol 500 Covid-19 patients admitted in 12 government hospitals.

“Through this study, MoH hopes to have a correct perspective on the clinical effectiveness of Ivermectin. 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 the steps necessary to figure out what really works. Without the benefit of evidence from well-designed clinical trials, the Ministry of Health Malaysia is not yet able 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 said.

Dr Noor Hisham explained that Ivermectin is an anti-parasitic drug mostly used in veterinary medicine, especially to treat worm infestations.

He said that in April last year, researchers using laboratory methods showed that Ivermectin can also inhibit the replication of SARS-CoV-2, the novel virus that causes the Covid-19 infection.

He added that since then, many authors relying on findings from small studies and case series have suggested the potential use of Ivermectin against the said virus, adding that the recommendation for the ‘off-label’ use of Ivermectin in Covid-19 cases, has, however, been controversial since the beginning.

“Firstly, many Ivermectin studies had limitations including small sample size, non-controlled study designs, or that the drug was 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 a reduction in the proportion of PCR positive patients at day seven, post-Ivermectin 400 mcg/kg single oral dose treatment.

“The authors of the pilot study, published in EClinical 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 (Jama) published a randomised-controlled trial involving 476 adults with mild Covid-19 disease was given a 5-day course of Ivermectin. The results showed that there was no significant improvement in Covid-19 symptoms resolution time. Whilst Ivermectin may have some anti-viral and anti-inflammatory effects, the evidence remains inconclusive,” he said.

Dr Noor Hisham said that regulatory bodies including the US’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA), after evaluating the said studies, concluded that there was insufficient evidence to support the use of Ivermectin as a treatment for Covid-19 infection.

He said that the World Health Organisation (WHO) had also issued guidelines against the routine use of Ivermectin for treating Covid-19 patients, except in clinical trial settings.

“Regardless of these decisions, support for Ivermectin as a “miracle drug” is being circulated by several NGOs and by those who want the drug repurposed against Covid-19. 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, the Civdac cites scientific proof on the utility of Ivermectin as recommended by some experts from US-based Front Line Covid-19 Critical Care (FLCCC). Yet, the synthesis of the evidence includes inferences only from preliminary reports of work without peer review, and opaqueness for risk of bias assessment of studies included in the body of evidence,” he added.

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