KUALA LUMPUR – The Health Ministry and Institute for Clinical Research (ICR) have started a clinical trial on the use and efficacy of ivermectin in high-risk Covid-19 patients at 12 government hospitals.
Health Director-General Tan Sri Dr Noor Hisham Abdullah said ivermectin is an anti-parasitic drug approved by the United States Food and Drug Administration (FDA), and widely used to treat tropical diseases including onchocerciasis, strongyloidiasis and helminthiases.
However, there is inconclusive evidence as to its use on coronavirus patients.
“The ‘off-label’ use of ivermectin gained global attention due to some promising results from case studies and clinical trials,” said Dr Noor Hisham in a statement yesterday.
“FDA has not approved ivermectin for use in treating or preventing Covid-19 in humans, and the World Health Organisation (WHO) recommends the use of ivermectin only in clinical trials, where patients are monitored closely by experienced clinicians and researchers.”
He said there is an ongoing need for adequately powered, well-designed and well-conducted trials on the role of ivermectin in Covid-19 treatment.
“Under the circumstances, the ministry and ICR have initiated a multi-centre, open-label, randomised controlled trial... (called) Ivermectin Treatment Efficacy in Covid-19 High-Risk Patients, headed by the infectious disease physician at Raja Permaisuri Bainun Hospital in Ipoh, and a team of specialists and clinical research centres at 12 hospitals under the ministry.”
He said the trial was approved by the ministry’s Medical Research and Ethics Committee on May 25, and will enrol 500 individuals from high-risk groups aged 50 and above who are admitted to hospital with mild to moderate Covid-19 symptoms.
“The study aims to determine the efficacy of ivermectin in preventing the progression of Covid-19 to a severe level (Stages 4 and 5), and in terms of mortality outcomes.
“ICR has set up a data monitoring board comprising independent physicians, clinical trial pharmacists and methodology experts to safeguard patients.”
He said the “first patient in” was on May 31, and to date, eight have been enrolled, with the study expected to be completed by September.
Dr Noor Hisham said the WHO Covid-19 Solidarity Trial for Covid-19 Treatments, which includes Malaysia, has found insufficient evidence for the use of Remdesivir, Hydroxychloroquine, Interferon and Lopinavir in terms of mortality outcomes.
At present, he said, the Malaysian Consensus Management Guidelines for Covid-19 maintains Favipiravir as the only antiviral therapy for the management of coronavirus cases.
“The Covid-19 clinical characterisation study by ministry specialists and researchers found that for cases admitted to hospital, 95% had mild illness, but about 3.5% subsequently progressed to severe disease.
“They were mostly older, aged over 51, or had underlying comorbidities, such as chronic kidney disease and chronic pulmonary disease, which increased their risk for severe (Covid-19) disease... however, for high-risk Covid-19 patients, many repurposed antiviral therapies have been found ineffective.”
He said the Randomised Evaluation of Covid-19 Therapy trial showed that dexamethasone, a steroid, improves mortality outcomes for coronavirus patients in the severe stage of the disease when oxygen aid or mechanical ventilation is required.
“But for the management of mild and moderate cases, there is a lack of treatment, either to prevent disease progression or cut viral transmission.” – Bernama, June 6, 2021
