The Institute for Clinical Research (ICR) NIH today announced findings for the Ivermectin study (I-TECH) in 500 hospitalised patients with Stage 2 or 3 COVID-19. This multi-centre open-label randomised controlled trial evaluated a 5-day course of ivermectin (0.4mg/kg/day) plus standard of care (IVM group), compared to standard of care (SOC group) according to Ministry of Health Malaysia (MOH) guidelines for COVID-19 patients at 20 government hospitals and MAEPS 2.0 Quarantine and COVID-19 Treatment Centre (PKRC).
The trial was conducted by infectious disease physicians and clinicians who were actively involved in COVID-19 management in collaboration with the Institute for Clinical Research (ICR), National Institute of Health (NIH). The main outcome of the I-TECH study was to see if ivermectin administered during the first week of illness prevented deterioration to severe COVID-19 Stage 4 or 5 among hospitalised patients aged 50 years and above with at least one comorbidity.
ICR Director, Dr Kalaiarasu M. Peariasamy, said the I-TECH findings showed that patients in the IVM group compared to SOC group had similar rates of progression to severe COVID-19 disease at 21.2 percent and 17.3 percent respectively (OR 1.29 [95% CI 0.82-2.02]; p = 0.30). 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.
This MOH initiated study obtained Medical Research and Ethics Committee (MREC) approval on 25th May 2021. In order to disclose to the public key information about the I-TECH study, the trial was registered in ClinicalTrials.gov on 31st May 2021 (NCT04920942). From the sample of 500 subjects enrolled in the trial, four (4) were excluded for not meeting study criteria and six (6) withdrew after expressing concerns about ivermectin side effects. The last subject was recruited on 9th October and the follow-up ended on 25th October 2021.
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.
Additionally, safety analysis showed three times more adverse events were reported in the IVM group versus the SOC group; most commonly diarrhea. Meanwhile, there was a trend of 28-day mortality reduction by IVM with standard of care, but not reaching statistical significance (OR 0.30 [95% CI 0.08-1.11]; p=0.09). 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 (13/490) which provided limited evaluation of the result.
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. The MOH continues with prior advice that ivermectin only be used within clinical trials settings with monitoring. This is also 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. The I-TECH study team plans to submit the data for publication in a peer-reviewed journal which can help provide additional research information for ivermectin studies including meta-analysis.
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.