Metro Manila — The national government is finalizing details of the clinical trial on the antiparasitic drug ivermectin since there is still no evidence it is effective against COVID-19.
Dr. Jaime Montoya, chief of the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD), said they are targeting to start the trial by end of May or first week of June.
Over 1,200 mild to moderate COVID-19 patients undergoing isolation in quarantine facilities could participate in the trial, but the number could eventually go up. The clinical trial – personally ordered by President Rodrigo Duterte – could run for six months or less, but it should be completed before yearend.
The DOST eyes recruiting patients in Metro Manila, the epicenter of the local coronavirus outbreak.
Montoya said it is important to conduct this trial since there is still no solid evidence to show ivermectin is effective in treating patients with mild to moderate symptoms.
“Kung sufficient ang evidence, bakit kami gagawa ng trial? [If the evidence is sufficient, why will we conduct a trial?]” he told a media briefing hosted by the Department of Health.
Dr. Marissa Alejandria, president of the Philippine Society for Microbiology and Infectious Diseases, reiterated the recent findings of fellow Filipino experts that there is insufficient evidence for now to recommend or prohibit the use of ivermectin.
The Living Clinical Practice Guidelines, crafted by health experts alongside the DOH and the Food and Drug Administration, also suggested against the use of ivermectin for severe and critical patients. They also advised against the use of ivermectin combined with doxycycline for COVID-19.
“What we are saying is that there is still insufficient evidence to give it to the general population. You can. But you have to explain. We are not preventing,” Alejandria said. “When there is insufficient evidence, it means you may or may not use the drug. But it is your responsibility to explain to the patient the status of the evidence.”
Alejandria added they are hoping the upcoming trial in the Philippines can provide more clarity on the effectivity of ivermectin against COVID-19. Montoya also said they can forward the results of the trial to the FDA so the ageny can be guided on issuing regulatory decisions.
The FDA, DOH, and several health experts, including the World Health Organization, have cautioned the public against using ivermectin for COVID-19 prevention or treatment.
Experts said there is not enough proof the drug can be used to treat or prevent COVID-19. They also warned high doses could cause brain damage in humans, or even death.
FDA Director General Eric Domingo, however, is not against personalities holding events giving away ivermectin. He said it is legal as long as a doctor will check the recipients before issuing a prescription. He said a compassionate special permit is unnecessary if the medicines will come from licensed compounding pharmacies.