KUALA LUMPUR: Ivermectin usage does not have significant effect on Covid-19 patients treated together with standard of care (SOC), compared with those treated with the latter alone, a study by Institute for Clinical Research Malaysia (ICR) revealed.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the open-label randomised trial done on 500 Covid-19 patients in categories 2 and 3 were aimed at determining the efficacy of five-day treatment using ivermectin (0.4mg/kg/per day) and SOC (IVM group), compared with standard treatment (SOC group).
It was conducted on patients at 20 government hospitals and MAEPS 2.0 Covid-19 quarantine and treatment centre based on the Health Ministry's guidelines.
"Dr Kalaiarasu M. Peariasamy, the ICR director, has informed that I-TECH study (Ivermectin) showed the Covid-19 disease worsening rate between IVM and SOC at 21.2 per cent and 17.3 per cent, respectively (OR 1.29 [95%] CI 0.82-2.02]; p=0.30).
"In the same findings, the average worsening period was at 3 days for IVM group, compared with 2.9 days for SOC, although statistically, there was no significant difference; p=0.68 (p value)," he said in a statement today.
Dr Noor Hisham said I-TECH was aimed to determine whether ivermectin usage on patients aged 50 and above, as well as those with one comorbidity, on the first week of Covid-19 symptoms could prevent them to worsen to categories 4 and 5.
The clinical study was conducted by infectious diseases specialists and medical specialists who were actively involved in Covid-19 management with the cooperation of ICR under the National Institute of Health (NIH), he said.
He said the study by Health Ministry was approved by the Ethics and Medical Research Committee on May 25.
"The study was also registered on ClinicalTrials.gov on May 31, 2021 (NCT04920942) to reveal crucial information related to I-TECH study to the public.
"Of the 500 subjects registered with the study, four people were exempted as they did not fulfil the study criteria, while six have withdrawn due to concern over the side effects of ivermectin," he said, adding that the last subject was recruited on Oct 9.
The final follow-up assessment was done on Oct 25, he said.
I-TECH lead researcher Dr Steven Lim Chee Loon, infectious disease specialist from the Raja Permaisuri Bainun Hospital, Ipoh, revealed that no significant difference was found in terms of ICU admission, usage of breathing support equipment, recovery of symptoms, blood test parameter and chest X-ray scans among the two groups.
The probability to fully recover from the symptoms on the fifth day among the two groups were almost similar, where there was no statistically significant difference was recorded (p=0.77), Dr Noor Hisham said.
"Apart from that, safety analysis reported a three-fold occurrence of side effects among IVM group, compared with SOC group, of which most of them were diarrhoea cases.
"Meanwhile, there was a downward trend of mortalities within 28 days for IVM, compared with SOC, although there the trend did not reach a significant result, statistically (OR 0.30 [95% CI 0.08-1.11]; p=0.09)."
According to Professor Dr Lai Nai Ming and Associate Professor Dr Karuthan Chinna from Taylor's School of Medicine who were responsible in preparing the independent statistics analysis, the I-TECH study could not verify findings that ivermectin could reduce deaths within 28 days, compared with SOC alone.
This is because the number of deaths was small (13/490), resulting in a limited assessment on the findings, said Dr Noor Hisham.
Based on I-TECH study findings, ivermectin was not recommended to be included in the existing Covid-19 treatment guidelines as it did not reduce the risks of Covid-19 later categories.
He said the ministry recommended that ivermectin is also used in clinical studies with monitoring, adding that findings from I-TECH were also in line with huge-scale studies like IVERCOR-COVID19 from Argentina and TOGETHER from Brazil that did not support ivermectin routine in Covid-19 clinical treatment.
He said the I-TECH study team planned to submit the data to be published in peer-reviewed journal to provide additional information to the studies on ivermectin, including meta-analysis.
"It is hoped that the local study could provide enlightenment to medical practitioners in Malaysia and the public who have been asking about the efficacy of ivermectin in Covid-19 clinical treatment practise.
"Medical practitioners are reminded not to recommend the use of ivermectin, including sharing advertisement or illegal sale of ivermectin to treat Covid-19 until more solid scientific evidence is available."