Data from Malaysia's Ivermectin study involving 500 COVID-19 patients show no difference in the rate of progression to severe stage. There are 3x more adverse events with Ivermectin, mostly having diarrhoea.
infection and could not be recommended for inclusion in current treatment guidelines, said a Health Ministry study. Health director-general Tan Sri Dr Noor Hisham Abdullah said in a statement that this was concluded in the Ivermectin study conducted by the Institute for Clinical Research .
The study included 500 hospitalised patients with Category 2 or 3 COVID-19 infections, who were split into two groups. One received a five-day course of Ivermectin plus standard of care , and the other was the standard of care group that were treated according to MoH guidelines for COVID-19 patients at 20 government hospitals and MAEPS 2.0 Quarantine and COVID-19 Treatment Centre . “According to the principal investigator of the I-TECH study, Dr Steven Lim Chee Loon, Infectious Disease Specialist at Hospital Raja Permaisuri Bainun, Ipoh, there were no significant differences found in terms of ICU admission, mechanical ventilation, symptom recovery, blood parameters and chest X-ray resolution in both groups. “The odds of complete symptom recovery by Day 5 of enrolment between IVM and SOC groups were very similar and not statistically significant; p=0.77,” he said. Dr Noor Hisham said that safety analysis showed three times more adverse events were reported in the IVM group versus the SOC group, most commonly diarrhoea, while there was a trend of 28-day mortality reduction by IVM with standard of care, but not reaching statistical significance. “According to Professor Lai Nai Ming and A/Professor Karuthan Chinna from Taylor’s School of Medicine who provided independent statistical analysis, the I-TECH study cannot confirm whether ivermectin administered in hospital compared with standard of care alone leads to fewer deaths at 28 days. “This is due to the small number of deaths which provided limited evaluation of the result,” he said. ICR director, Dr Kalaiarasu M. Peariasamy, said the I-TECH findings showed that patients in the IVM group compared to the SOC group had similar rates of progression to severe COVID-19 disease at 21.2 per cent and 17.3 per cent respectively. “For the same primary outcome, the mean time to progression was 3.0 days for the IVM group compared to 2.9 days for the SOC group, but the difference was not statistically significant; p=0.68,” said Dr Kalaiarasu. The Health Ministry had obtained Medical Research and Ethics Committee approval on May 25 and for transparency, the trial was registered in ClinicalTrials.gov on May 31, 2021. Dr Noor Hisham said that the findings of this study are supported by other recent large studies such as IVERCOR-COVID19 from Argentina and TOGETHER from Brazil which do not support the routine usage of Ivermectin in clinical practice. “It is hoped that the findings of this local study can help to inform medical practitioners in Malaysia and also to the public, who often ask about the effectiveness of Ivermectin in the clinical practice of COVID-19 treatment. “Until further supportive evidence becomes available, practitioners are cautioned not to recommend Ivermectin including sharing illegal advertising or sale of Ivermectin for treatment of COVID-19,” he said. —Based on the outcomes of the I-TECH study, ivermectin cannot be recommended for inclusion in current COVID-19 treatment guidelines as ivermectin does not reduce risk of severe illness from COVID-19.
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