Dr Noor Hisham: Health Ministry has begun Ivermectin trial for high-risk Covid-19 patients


KUALA LUMPUR (Bernama): The Health Ministry and the Institute for Clinical Research (ICR) have started clinical trials to study the use and efficacy of Ivermectin for high-risk Covid-19 patients at 12 of the ministry's hospitals.

Health director-general Tan Sri Dr Noor Hisham Abdullah said Ivermectin is a Food and Drug Administration (FDA) approved anti-parasitic drug widely used for treating several neglected tropical diseases, including onchocerciasis, strongyloidiasis and helminthiases, however, the evidence is inconclusive to recommend routine use of Ivermectin for Covid-19 patients.

"The ‘off-label’ use of Ivermectin gained global attention due to some promising results by case studies and clinical trials.

"The FDA has not approved Ivermectin for use in treating or preventing Covid-19 in humans, and the World Health Organisation (WHO) only recommends the use of Ivermectin in a clinical trial setting, in which patients are monitored closely by experienced clinicians and researchers for safety and efficacy," he said in a statement Saturday (June 5).

He said there is an ongoing 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.

"Under the circumstances, the Ministry and ICR have initiated a multicentre open-label randomised controlled trial... the Ivermectin Treatment Efficacy in Covid-19 High-Risk Patients (I-TECH Study) headed by the Infectious Disease (ID) physician at Raja Permaisuri Bainun Hospital, Ipoh and a team of specialists and Clinical Research Centres (CRC) at 12 Ministry hospitals," he said.

Dr Noor Hisham said the trial was approved by the ministry’s Medical Research and Ethics Committee on May 25, where the study compares Ivermectin treatment (specific dose with specific duration) with the standard of care alone.

He said the study would enrol 500 subjects from high-risk groups aged 50 years and above admitted to Health Ministry hospitals with mild or moderate Covid-19 symptoms (stage two to three).

"The study aims to determine the efficacy of Ivermectin in preventing the progression of Covid-19 to severe disease (stage four and five) and in terms of mortality outcomes.

"ICR has set up a Data Monitoring Board (DMB) consisting of independent ID physicians, clinical trial pharmacists and methodological experts to safeguard the trial patients on the safety and efficacy of the investigation product set by the National Pharmaceutical Regulatory Agency (NPRA)," he said.

He added the First-Patient-In (FPI) was on May 31 this year and to date, eight patients have been enrolled, where the study is expected to be completed by Sept 2021.

Meanwhile, Dr Noor Hisham said the WHO Covid-19 Solidarity Trial for Covid-19 Treatments (Solidarity) which included Malaysia, found insufficient evidence for the use of Remdesivir, Hydroxychloroquine, Interferon and Lopinavir in terms of mortality outcomes.

He said currently the Malaysian Consensus Management Guidelines for Covid-19 maintains Favipiravir as the only anti-viral therapy for the management of COVID-19 cases, adding even this recommendation may change as more evidence becomes available.

"The Covid-19 clinical characterisation study by MOH specialists and researchers found that for cases admitted to hospitals, 95% had a mild illness but about 3.5% subsequently progressed to severe disease.

"They were mostly of the older age of more than 51 years old or had underlying co-morbidities such as chronic kidney disease and chronic pulmonary disease that increased their risk of severe disease... however, for high-risk Covid-19 patients, many repurposed antiviral therapies were found ineffective," he said.

Meanwhile, he said the Randomised Evaluation of Covid-19 Therapy (Recovery) trial showed dexamethasone, a steroid, improved mortality outcomes for Covid-19 patients in the severe stage of 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," he said, adding effective pharmacologic treatments for Covid-19 remained a challenge. - Bernama

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