MANILA - Ivermectin, the controversial drug said to help treat COVID-19, was proven ineffective in preventing severe COVID-19 in a Malaysian study done among 490 patients.
"In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19," read the study, a copy of which was published last Friday on JAMA Network.
Enough studies are now available to recommend against the use of ivermectin on COVID-19 patients, said Dr. Rontgene Solante of the Philippine Society for Microbiology and Infectious Diseases (PSMID).
“It significantly tells us that ivermectin doesn’t work and is not effective in the prevention of severe infection or severe COVID among those who will be getting this treatment. That’s an indication na we don’t need ivermectin for the treatment of COVID-19.”
Last year, the Philippines' Food and Drug Administration granted Compassionate Special Permits (CSP) to several hospitals for the use of ivermectin in treating COVID-19 patients.
This despite a recommendation from the Philippine COVID-19 Living Clinical Practice Guidelines of the PSMID against the use of ivermectin for COVID-19 patients.
Solante said the CSP may have been issued due to the lack of evidence against ivermectin at the time, but this should now be revisited.
"Kaya binigyan pa rin sya ng CSP kasi wala pa tayong masyadong malawak na data on that. That should be revoked because of that data. It’s up to FDA to revisit the data and inform the evaluation, and give a recommendation again," the infectious disease specialist said in an interview with ABS-CBN News.
(It was granted a CSP because we did not have much data at the time. It should be revoked now because of the new information that we have.)
According to Solante, the randomized control methodology of the study in Malaysia effectively concludes that ivermectin does not prevent severe COVID-19.
The study was done on 490 patients diagnosed with the mean age of 62.5 years. Approximately two-thirds of patients had moderate COVID-19.
Of the total, 241 were in the intervention group and 249 in the control group.
The intervention group received 5 doses of ivermectin.
"There were no significant differences between ivermectin and control groups," the study read.
"This will give now a better view among clinicians who are using ivermectin that it’s not working. It’s flat out, not working. Why should we be using a drug [if] it’s not working?" Solante said.
Additionally, because the trial was done in Malaysia, it may have more value to neighboring Asian countries.
"It’s done in Malaysia. These are Asian countries, meaning the same characteristics as that with Filipinos. So this will give more value sa (among) Asian countries," said Solante.
In a statement, the Department of Health and the FDA echoed the results of the study.
"The Department of Health (DOH) and the Food and Drug Authority (FDA) would like to reiterate that the use of anti-parasitic drug Ivermectin for the treatment of COVID-19 is not recommended because it had no significant effect on symptom resolution and hospitalization rates as well as it did not reduce the risk of developing severe disease according to the findings of recently published scientific journal articles," the statement read.
It clarified that the only registered oral and intravenous ivermectin products are for the medication of animals.
Approved and available ivermectin products on humans are exclusive to topical medication for lice and other skin conditions.
It also mentioned that the CSP is granted to allow physicians and hospitals the limited use of unregistered medical products.
"That should close the chapter on ivermectin and focus on those drugs that are already available and has benefits," Solante said.