Malaysia begins Ivermectin trial for high-risk COVID-19 patients


By NewsDesk @infectiousdiseasenews

Effective pharmacological treatments for COVID-19 remain a challenge. The Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial showed dexamethasone, a steroid, improved mortality for COVID-19 patients in severe disease stages when oxygen supplementation or mechanical ventilation was required. However, for the handling of mild and moderate cases, treatment is still lacking, either to prevent the development of the disease or to stop the transmission of the virus.

Image by Gerd Altmann from Pixabay

A clinical characterization study of COVID-19 by MOH specialists and researchers found that for hospitalized cases, 95% had mild disease but about 3.5% later progressed to severe disease. They were mostly older (≥51 years) or had underlying comorbidities such as chronic kidney disease and chronic lung disease that increased the risk of severe disease. However, for high-risk COVID-19 patients, many reused antiviral therapies have been found to be ineffective. The World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatment (SOLIDARITAS) which includes Malaysia, found insufficient evidence for the use of remdesivir, hydroxychloroquine, interferon, lopinavir in terms of mortality outcomes. Currently, the Malaysian Consensus Management Guidelines for COVID-19 maintain Favipiravir, as the only antiviral therapy for the management of COVID-19 cases. Even these recommendations are subject to change as more evidence becomes available.

Ivermectin is an FDA-approved anti-parasitic drug widely used to treat several neglected tropical diseases, including onchocerciasis, strongyloidiasis, and helminthiase. The “off-label” use of Ivermectin is gaining global attention due to some of the promising results through case studies and clinical trials. However, 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 WHO only recommends the use of Ivermectin in clinical trial settings, where patients are closely monitored by experienced physicians and researchers for safety and efficacy. There is an ongoing need for sufficiently powered, well-designed, and well-conducted clinical trials for evidence-based guidance on the role of Ivermectin in the treatment of COVID-19.

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In this situation, the Malaysian Ministry of Health and the Institute for Clinical Research (ICR) have initiated a multicenter open-label randomized controlled trial. Ivermectin Treatment Efficacy in Covid-19 High-Risk Patients (I-TECH Study) led by Infectious Disease (ID) Physician at Raja Permaisuri Bainun Hospital, Ipoh and a team of specialists and Clinical Research Center (CRC) at 12 Ministry of Health Hospitals. This trial was approved by the Committee for Medical Research and Ethics (MREC), MOH on 25 May 2021. This study compared Ivermectin treatment (specific dose with specific duration) with standard of care alone. This study will enroll 500 subjects from the high-risk group aged 50 years and over who are admitted to a Ministry of Health hospital with mild/moderate COVID-19 symptoms (Stage 2-3). This study aimed to determine the efficacy of Ivermectin in preventing the progression of COVID-19 to severe illness (Stage 4-5) and in terms of mortality outcome. The ICR has set up a Data Monitoring Board (DMB) consisting of independent ID physicians, clinical trial pharmacists, and methodologists to protect trial patients about the safety and efficacy of investigative products established by the National Pharmaceutical Regulatory Agency (NPRA).

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First-Patient-In (FPI) on May 31, 2021, and so far 8 patients have been registered. The study is expected to be completed in September 2021.

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