KUALA LUMPUR – The Institute for Clinical Research (ICR), National Institute of Health (NIH) which conducted studies on the use of Ivermectin (I-Tech) on 500 Covid-19 patients found that Ivermectin did not prevent Covid-19 from becoming worse.
Therefore, the Ministry of Health (MOH) would not recommend the use of Ivermectin in the Covid-19 treatment guideline.
Director-General of Health, Tan Sri Noor Hisham Abdullah said that the I-Tech Study on 500 Covid-19 patients who were admitted into the hospital with category 2 and 3 symptoms were evaluated for 5 days on Ivermectin treatment (0.4mg/kg/day) efficacy, along with standard treatment (IVM group) versus the standard treatment group (SOC group) that was based on the MOH guideline for patients in 20 government hospitals ant the MAEPS Covid-19 Quarantine and Treatment Centre 2.0.
The clinical trial was conducted by infectious diseases medical specialists and medical specialists who are actively involved in the management of Covid-19 with the cooperation of the ICR under NIH.
The main findings of I-Tech was to see if the administration of Ivermectin during the first week of patients experiencing symptoms of Covid-19 can stop the disease from becoming worse (Category 4 or 5) among patients aged 50 years and above with at least one comorbidity.
He said, Dr. Kalaiarasu M. Peariasamy, the Director of ICR said that the I-Tech showed similar deterioration of condition in Covid-19 patients between IVM (21.2%) and SOC (17.3%).
In the same finding, the average deterioration period was 3.0 days for IVM compared to 2.9 days for SOC. Nevertheless, it was not a statistically significant difference.
Noor Hisham said that the trial conducted by MOH received the approval of the Medical Ethical and Research Committee on 25 May 2021.
The trial was also registered at https://clinicaltrials.gov/ on 31 May 2021 to reveal vital information on I-Tech to the public.
From the 500 subjects registered in the trial, four individuals have been exempted as they did not fulfil the criteria of the trial, meanwhile, six individuals withdrew themselves due to their concerns over the side effects of Ivermectin.
According to its main researcher, Dr. Steven Lim Chee Loon, Infectious Disease Specialist from the Raja Permaisuri Bainun Hospital in Ipoh, no statistically significant difference was recorded in ICU admission rate, the use of mechanical respiratory support equipment, symptoms recovery, blood test parameters and the chest X-Ray resolution between the two groups.
The probability to fully recover on the fifth day between the IVM and SOC are almost the same with no statistically significant difference.
Besides that, the safety analysis reported that the side effects is three times higher in the IVM group compared to the SOC group; which were mainly diarrhoea cases.
Meanwhile, there was a trend on the reduction of mortality rate within a period of 28 days for the IVM group compared tot eh SOC. However, it was not statistically significant.
According to Professor Dr. Lai Nai Ming and Associate Professor Dr. Karuthan Chinna from the Taylor’s School of Medicine who prepared the independent statistics analysis on the I-Tech, they couldn’t verify that the use Ivermectin in the hospital can reduce death within 28 days compared to the standard treatment.
The number of deaths was too small (13/490) and this caused a limited evaluation on the findings.
“Based on the I-Tech study, Ivermectin is not recommended to be included into the existing Covid-19 treatment guideline as it cannot reduce the risk of Covid-19 infection from becoming severe.
“MOH recommends that Ivermectin is only used in clinical trial under observation. The I-Tech finding corresponded to the large-scale trial such as IVERCOR-COVID19 from Argentina and TOGETHER from Brazil that did not support the routine use of Ivermectin in the clinical treatment of Covid-19,” he said.
The I-Tech research team suggested to send the data of the trial to be published in a peer-reviewed journal to provide extra information on the Ivermectin trials, including the meta-analysis.
Noor Hisham hoped that the local trial could provide a clearer information to medical practitioners in Malaysia and the general public who often question about the efficacy of Ivermectin in the clinical practice of Covid-19 treatment.
Therefore, medical practitioners are urged not to recommend the use of Ivermectin, including by sharing its advertisement or illegally selling Ivermectin for the treatment of Covid-19 until more solid scientific evidence is found. -MalaysiaGazette
