DOST OK with clinical trial to test ivermectin vs COVID-19

ABS-CBN News

Posted at Apr 20 2021 02:48 AM | Updated as of Apr 20 2021 11:13 AM

DOST OK with clinical trial to test ivermectin vs COVID-19 1
The anti-parasitic drug ivermectin is widely circulating on the internet as an alternative drug against COVID-19. ABS-CBN News/File

MANILA (2nd UPDATE)—The Department of Science and Technology (DOST) on Monday said the Philippines will be conducting a clinical trial to determine the effectiveness of ivermectin against COVID-19. 

The development contradicted a previous statement by the department's head that such a trial was not needed because there was a number of others being done already. 

DOST Secretary Fortunato dela Peña said in an aired public briefing he had an agreement with Health Secretary Francisco Duque III on Saturday they will look for experts to handle the trial.

Dr. Aileen Wang of the UP-PGH Department of Medicine is part of the trial panel, Dela Peña said.

"Hopefully po 'pag natapos 'yung trial na 'yan, ay magkaroon tayo ng mas reliable estimate ng epekto ng ivermectin bilang isang anti-viral agent na makakapag-reduce po nung virus shedding sa mga mild at moderate (COVID-19) patient," the secretary added.

(Hopefully the trial will show more reliable estimates of ivermectin's effects as an anti-viral agent that will reduce virus shedding of mild and moderate patients.)

Only patients of at least 6 quarantine centers near UP-PGH will be included in the clinical trial which will be "good for 8 months," Dela Peña told ABS-CBN's Teleradyo on Tuesday.

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Only a week ago, the DOST secretary said there was no need for conducting an ivermectin clinical trial as it can "require a minimum of 6 months and can extend to years", and there are 20 "almost completed" and 40 "ongoing" clinical trials on its efficacy in treating COVID-19 worldwide.

He added that DOST's Philippine Council for Health Research and Development "issued the position that there is no need to conduct another clinical trial in the Philippines as most ongoing trials or clinical trials already been started since 2020."

"It would be appropriate to await the results of these studies that already significantly advanced in terms of data collection and conducting interim analysis," Dela Peña had said. 

Last week, the Philippine Food and Drug Administration granted a second hospital a special permit to use ivermectin for its COVID-19 patients, acknowledging there was some "pressure" to approve it.

The drug regulator explained the compassionate special permit allows experimental or unregistered drugs for limited off-label use, but acquiring one does not mean the medication is proven to be effective since that requires a clinical trial. 

Registered ivermectin products are for veterinary use only and are only to treat internal and external parasites, as well as prevention of heartworm disease, the health department earlier said.

Unauthorized use of veterinary drugs could lead to brain damage and death, infectious disease expert Dr. Edsel Maurice Salvana noted.

The World Health Organization (WHO) has recommended against using ivermectin on patients with COVID-19, except for clinical trials, because of a lack of data demonstrating its benefits.

Dela Peña meanwhile said they are looking into other medication, such as melatonin and methylprednisolone, and herbal treatments such as lagundi, tawa-tawa and virgin coconut oil.

FDA director general Eric Domingo, meanwhile, said there are 88 vaccines in clinical development worldwide, and 184 others in pre-trials.

'NO EFFECT'

A special adviser to the National Task Force Against COVID-19 on Tuesday cautioned the public on using ivermectin to prevent or treat COVID-19 citing potential side effects.

"It's best not to take this on your own. Not from the advice of a social media app... Go to a real doctor that will tell you and can watch you," Dr. Ted Herbosa told ANC. "It's not as safe as it is proposed as you read on social media. There are many things still unknown about the use of ivermectin for COVID-19."

Herbosa warned that high doses of ivermectin could cause serious harm. 

"The dose to weight ratio is sensitive because the complications increase when you start to increase the dose. When you increase the dose, it can damage the liver, the kidney and it can enter the brain where it is toxic," he said.

Citing a peer-reviewed study published in the Journal of the American Medical Association on March 4, Herbosa said a randomized clinical trial "found no effect" on using ivermectin for patients with mild COVID-19.

"Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms," the paper read. 

"The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes." -- With a report from Joyce Balancio, ABS-CBN News

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