Ivermectin clinical trials begin
GEORGE TOWN: A Health Ministry study to assess the efficacy of the drug Ivermectin in preventing severe Covid-19 disease will involve 500 patients, according to the infectious disease expert heading it.
Dr Steven Lim Chee Loon (pic) said the main objective was to determine if the drug could be an effective antiviral therapy in the early stage of Covid-19, and prevent patients from slipping into the severe Categories Four and Five.
“We will also look at the differences in mortality, mechanical ventilation, intensive care unit (ICU) stay, symptoms resolution and adverse effects,” he said when interviewed.
Dr Lim is the lead principal investigator of the study “Ivermectin Treatment Efficacy in Covid-19 High Risk Patients”, better known as I-TECH Study, announced by Health director-general Tan Sri Dr Noor Hisham Abdullah in June.
Besides infectious disease physicians, the 140-member investigating team also comprises medical specialists, medical officers, pharmacists and research officers from Clinical Research Centre (CRC) from 18 government hospitals.
It was reported that the ministry and the Institute for Clinical Research (ICR) have started clinical trials to study the use and efficacy of Ivermectin for high-risk Covid-19 patients at 12 hospitals.
Category Four patients are those having pneumonia and requiring supplemental oxygen while Category Five patients are critically ill and needing to be intubated or put on a ventilator.
Ivermectin has been used for decades to treat head lice and river blindness in humans and heartworms in animals.
Dr Lim, who is with Hospital Raja Permaisuri Bainun in Ipoh, said the clinical trial would involve Covid-19 patients aged 50 and above with at least one comorbidity and admitted to hospital with mild symptoms during the first week of their illness, adding that patients would be randomised into two groups.
One group will receive oral Ivermectin at a dose of 0.4mg/kg (based on body weight) per day for five consecutive days while the other group would just get standard care without the drug, he said, adding that 200 patients have been recruited so far.
“It is important to note that the dose of ivermectin used in our clinical trial is higher than the approved dose for parasitic infection.
“Data from previous laboratory and clinical studies suggested that the proposed antiviral effects of Ivermectin in Covid-19 are dose dependent.
“Our study subjects are closely monitored by experienced physicians for any adverse events during the study period,” he said, adding that the 500-patient target was expected to be met by September.
“I’m proud to say that we have a strong and experienced research team working tirelessly on this project amid the worst period of the pandemic.
“We also have a strong collaboration with the ICR which provides us assistance in terms of study design, statistical analysis and data safety monitoring,” he said.
Dr Lim said the study was registered in clinicaltrials.gov and those interested could view the study protocol for details, adding that this will also ensure research transparency and prevent future publication bias.
He said the efficacy of Ivermectin as a drug for Covid-19 treatment must be based on scientific evidence and not personal opinion or public sentiment.
To date, he said evidence of Ivermectin in such treatment was still littered with conflicting data with persistent divided opinion among doctors and researchers worldwide.