PUTRAJAYA, 5 June 2021:
Malaysia’s Health Ministry (MoH) has begun trials using Ivermectin as treatment for Covid-19 infections – with the first patient admitted into this trial on May 31 May 2021.
Health director-general Tan Sri Dr Noor Hisham Abdullah said in a statement that eight patients have so far been enrolled and this study is expected to be completed by September.
He explained this study is critical as effective drug treatments for Covid-19 remains a challenge, explaining MoH studies had found of cases admitted to hospitals, 95% had mild illness – but about 3.5% subsequently progressed to severe disease.
“Those severely affected were mostly of older age (≥51 years) or had underlying co-morbidities such as chronic kidney disease and chronic pulmonary disease that increased their risk for severe disease.”
Still, he noted trials had shown dexamethasone, a steroid, improved mortality outcomes for Covid-19 patients in severe stages of the disease when oxygen supplementation or mechanical ventilation is required.
“But for the management of mild and moderate cases, there is lack of treatment, either to prevent disease progression or cut viral transmission.”
Noting many repurposed antiviral therapies were found ineffective, he said a global World Health Organisation (WHO) Solidarity Trial – which included Malaysia – found insufficient evidence for the use of remdesivir, hydroxychloroquine, interferon, lopinavir to reduce Covid-19 deaths.
“Currently, the Malaysian Consensus Management Guidelines for Covid-19 maintains Favipiravir, as the only antiviral therapy for the management of Covid-19 cases. Even this recommendation may change as more evidence becomes available.”
Explaining why the trial is being conducted with Ivermectin – an anti-parasitic drug widely used for treating several neglected tropical diseases, including onchocerciasis, strongyloidiasis and helminthiases – approved by the US Food and Drug Administration (FDA), Dr Noor Hisham said this is in line with WHO advice.
“The evidence is inconclusive to recommend routine use of Ivermectin for Covid-19. The FDA has not approved Ivermectin for use in treating or preventing Covid-19 in humans, and the WHO only recommends the use of Ivermectin in the setting of clinical trials, in which patients are monitored closely by experienced clinicians and researchers for safety and efficacy.
“There is an on-going need for adequately powered, well-designed, and well-conducted clinical trials for evidence-based guidance on the role of Ivermectin in the treatment of Covid-19.”
He said MoH and the Institute for Clinical Research have initiated a multicentre open-label randomised controlled trial – the Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study) headed by infectious disease physician at Hospital Raja Permaisuri Bainun, Ipoh and a team of specialists and Clinical Research Centres at 12 MoH hospitals.
“The trial was approved by Medical Research and Ethics Committee, MoH on 25 May 2021. The study compares Ivermectin treatment (specific dose with specific duration) with the standard of care alone. The study will enrol 500 subjects from high risk groups aged 50 years and above admitted to MoH hospitals with mild/moderate COVID-19 symptoms (Stage 2-3).
“The study aims to determine the efficacy of Ivermectin in preventing the progression of Covid-19 to severe disease (Stage 4-5) and in terms of mortality outcomes,” Dr Noor Hisham said, assuring necessary precautions are in place to safeguard the trial patients.