The health ministry has found in its latest study that the drug does not reduce the risk of severe disease in high-risk patients.

The study, called I-Tech, showed no significant difference in ICU admissions, mechanical ventilation, symptom recovery, blood parameters and chest X-ray resolution between a group receiving the drug and the group receiving the ministry’s standard care.

Pro-Ivermectin groups, however, are not happy with the result, claiming that the study was designed to fail.

They alleged that those selected for the study were Category 3 Covid-19 patients, which means it was too late to prevent the cases from deteriorating to the severe stages of Categories 4 and 5.

They also said patients aged 50 and above, with at least one comorbidity were selected, making the likelihood of their deterioration to a severe stage high.

They said the study should instead have targeted Category 1 (asymptomatic) and 2 (symptomatic) cases because Ivermectin is most effective for prevention, less for early treatment and least for late treatment.

Is there any basis to the claims? No, says I-Tech principal investigator Dr Steven Lim Chee Loon.

He said the study was an early intervention trial with patients selected within the first week of showing symptoms.

“Ivermectin was given to mild to moderate Category 2 and 3 patients who were symptomatic, with or without pneumonia, but did not require oxygen support,” he added.

Lim is an infectious diseases (ID) specialist at Hospital Raja Permaisuri Bainun in Ipoh.

During a recent online media briefing on the I-Tech study, he cited guidelines saying a patient in a severe disease stage is categorised as one who needs oxygen support.

He also explained that the high-risk patients selected for the study were hospitalised not because they were severely ill but because the health ministry proactively admitted them for monitoring.

Lim said high-risk Category 1 patients were not recruited because they would rarely progress to severe stages and so it did not make sense to give them the drug.

“Such patients have a much lower risk of progression,” he said. “Our previous data showed that only 5.6% of them deteriorated. However, for high-risk patients in Categories 2 and 3, up to 17.5% progressed to severe disease.”

He said this was why people in the second group were targeted for the study. The death rate among such patients was 6.2% compared with 1.2% for the general population.

Selection bias

The data, collected by the ministry from Feb 1 to May 30 last year, was published in the Lancet Regional Health – Western Pacific.

Although the pro-Ivermectin group sees the selection of high-risk older folk with comorbidities as biased, Lim said targeting a younger group might not be beneficial. Local data showed that 95% of the young without comorbidities recovered without any medication.

With limited resources, it made sense that the ministry wanted to find a remedy for those in the high-risk group from progressing to severe disease or death rather than focus on the low-risk group.

However, could a balance have been struck somewhere for the drug to be given early enough?

As pro-Ivermectin groups argue that it was too late to give the drug to high-risk Category 3 patients, could researchers have tried out the study with Category 2 patients or retrieved more data from just Category 2 patients?

There have been claims on social media that more patients in the Ivermectin group progressed to severe disease than did the standard-care control group – 21.2% and 17.3%, respectively – but at a probability value (p-value) of 0.30, it was statistically not significant, according to Institute for Clinical Research director Dr Kalaiarasu M Peariasamy.

The mean time to progression was three days for the Ivermectin group and 2.9 days for the control group, which, at 0.68 p-value, was also not statistically significant.

Patients in the two groups had similar rates of progression to severe Covid-19 disease.

Likewise, the claim that only three in the Ivermectin group died compared with 10 in the control group, suggesting that the drug worked, was inaccurate since the p-value was 0.09.

According to Lim, it was statistically not significant due to the small total number of deaths (13 out of 490) and so researchers could not make any conclusion.

He rejected the claim that the I-Tech study used a single dose of 12mg of Ivermectin a day for five days, which pro-Ivermectin groups say was too low for Category 3 patients.

“The dose used in the I-Tech study was commonly used in trials. Also, a person who weighed 60kg or more would receive a 24mg dose daily, more than the 12mg to 14mg proposed by Ivermectin proponents.

He noted that there was currently no consensus among scientists on what would constitute the best dose.

Ivermectin as a prophylaxis

On the case for Ivermectin to be used as a prophylaxis and early treatment, deputy health director-general Dr Hishamshah Mohd Ibrahim said the ministry was awaiting the results of bigger studies.

He said taking it as a prophylaxis had its setbacks.

“The pandemic has been ongoing for two years. So, are you saying that we use Ivermectin for two years? That’s very concerning and will subject people to a lot of side effects.”

For this reason, the health ministry, in considering a study on Ivermectin’s efficacy as a prophylaxis and early treatment, will narrow it down to only those aged 18 and above and who have been in close contact with Covid-19 patients.

Judging from information shared through social media and webinars, there are various cocktails of therapy being used illegally out there. Ivermectin has been combined with other drugs or silver, zinc, vitamin C and vitamin D.

Anecdotes of patients recovering quickly from the therapies have been shared, with some claiming that patients’ oxygen level increased to normal levels within hours after therapy.

The question to be asked is: Did a patient recover with the help of drugs or zinc or vitamin C, oxygen support or just with adequate rest? This requires a systematic study in a clinical trial.

As family medicine specialist Dr Suhazeli Abdullah said in a recent webinar: “If a man eats nasi dagang every morning and later recovers from Covid-19 infection, can he claim that nasi dagang was the reason that he got well?”

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