KUALA LUMPUR, Nov 7 — Deworming medication Ivermectin is not a miracle drug that can cure Covid-19 patients, the Health Ministry asserted today.
Its principal investigator in the ministry’s Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH) Dr Steven Lim Chee Loon told reporters that widespread usage of the parasitic drug outside of a hospital setting without medical supervision may cause more harm than what is observed in clinical trials.
“Ivermectin is not a miracle drug for Covid-19, not as what some of the Ivermectin proponents have been claiming.
“It’s highly irresponsible, to be honest, especially coming from a doctor if you say Ivermectin is a miracle drug because when you say it’s a miracle drug to a lay person, it means a miracle drug where you will not get severe disease if you pop a tablet, especially to those who are uneducated,” said Dr Lim, an Infectious Diseases Specialist at Hospital Raja Permaisuri Bainun in Ipoh, Perak.
He had earlier presented the ministry’s findings to reporters following an in-depth study of Ivermectin on Covid-19 patients with mild to moderate symptoms during early disease of coronavirus.
He explained that the study’s primary endpoint was to determine the number of patients who progressed to severe disease (clinical stage 4 or 5) and other clinical outcomes of using Ivermectin in high-risk Covid-19 patients.
In his presentation, Dr Lim said the study started on May 31 this year and recruited 500 patients as trial subjects at 21 study sites.
“Yes, we know Ivermectin is generally a safe drug, but when used in a disease that has no effect at all, it will give false assurance and may be detrimental to the patients because they have false assurance when they don’t come to seek proper medical intervention.
“We only use drugs or medication if it’s proven efficacious. Those are fundamental facts. we only use it if it’s effective regardless of whether it’s cheap, old or safe,” he said.
As the lead investigator, Dr Lim said there were numerous false narratives with regards to the ministry’s I-TECH study where attempts were made to discredit or undermine the findings.
He said it is crucial for healthcare professionals to follow the science in a pandemic as there have been numerous false narratives propagated by certain groups.
On why trial subjects were not recruited from the Stage 1 patients group, Dr Lim explained said patients, especially low-risk ones, rarely progressed onto the advanced infection stage.
“So it doesn’t make sense to see the effect of antivirals for progression to severe disease if you give it to the population where they’re not going to progress to severe disease at all.
“It also makes sense in terms of clinical practice as to why we want to give a drug to someone who is not going to progress to severe disease,” he said, stressing that the primary antiviral role is to reduce viral load and prevent progression to severe disease.
As for the sample size, which has become a subject of contentious debate among Ivermectin advocates, Dr Lim said the figure was adequate for determining the study’s primary endpoint — which is whether the administration of Ivermectin in cases of early mild to moderate Covid-19 prevents progression to severe disease as this directly impacts the healthcare system, in particular hospitals.
“When it comes to clinical trials, when we talk about sample size, it doesn’t mean 1,000 is better than 500, or 10,000 is better than 1,000.
“It really depends on the primary outcome. If your primary outcome is progression to severe disease, then you base it on incidents you expect to find in doing a clinical trial and calculate accordingly to have an adequate sample size so your data can detect a positive effect, and if there is one, we are able to detect the positive effect of the drug or intervention,” he said.
According to a breakdown of the subjects’ characteristics, a total of 223 males and 267 females took part in the primary analysis after four were excluded and six withdrew from the study from the initial 500 subjects enrolled.
From the remaining 490, 254 or 51.8 per cent of the subjects were also fully vaccinated.
Based on the primary outcome findings, Dr Lim said Ivermectin does not prevent severe disease when administered to high-risk Covid-19 patients during their first week of illness.
For the control group, 17.3 per cent or 43 out of 249 patients deteriorated to severe disease, while the Ivermectin group saw 21.2 per cent or 51 out of 241 patients progressing to severe disease.
“I have to reiterate again that the I-TECH study was powered to assess the efficacy of Ivermectin in preventing the progression to severe disease in Covid-19.
“This is what we can make a conclusion out of it because our sample size is powered for this primary outcome.
“If there is a positive effect, definitely our study will be able to detect that effect, but unfortunately, it has not detected that effect because the proportion of severe disease are almost the same in both groups,” he said.
As for the secondary outcome findings, Dr Lim, however, said while there was a trend of 28-day mortality reduction by Ivermectin, it was statistically not significant, largely due to the small total number of deaths (13 out of 490 subjects).
For the control group, 4 per cent or 10 out of 249 patients’ deaths were recorded, while the Ivermectin group saw 1.2 per cent or three out of 241 patients’ deaths reported.
He explained that there is a possibility that the ceiling of care for elderly subjects with poor prognosis may be confounding factors to the figures as physicians may not be aggressive enough in terms of intervention where it might not be equally applied to all patients.
“Again, the I-TECH study was not powered for mortality endpoint but we did do some analysis on patients who died and did not find any significant variables that can contribute to this difference in death numbers,” Dr Lim said.
The briefing’s moderator, deputy health director-general (Research and Technical Support) Datuk Dr Hishamshah Mohd Ibrahim said the false sense of security perpetuated by self-medicating with Ivermectin was a matter of concern.
“We have seen this in our population, just because you are taking Ivermectin, I mean they have this false sense of security that all is going to be well, and then they come to the hospital late. By then, they have already progressed to the later categories and these people cannot be saved.
“This false information is giving false ideas to people that it can prevent progression of disease in Covid-19, so that is something we want to avoid in giving this false message to the public,” he said.
On a separate matter, Institute for Clinical Research (ICR) director Dr Kalaiarasu M. Peariasamy confirmed the ministry was mulling the possibility of conducting another study on Ivermectin using a randomised double blind placebo control (RDBPC) research design.
This time, he said, the focus would be on its efficacy as a prophylaxis for those aged above 18 and early preventive treatment for Covid-19 involving known close contacts of a confirmed Covid-19 patient.
Considered the “gold standard” of epidemiologic studies, RDBPC prevents bias as neither patients nor researchers know who is getting what treatment and a placebo is given after subjects are randomly assigned to the respective groups.
Prophylaxis or preventive healthcare is defined as a process of guarding against the development of a specific disease by a treatment or action that affects pathogenesis.
Dr Kalaiarasu, however, said clinicians and researchers were currently awaiting clearance from the National Pharmaceutical Regulatory Agency (NPRA), with the study expected to commence any time from now towards the end of this year.
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