The University of Philippines-Philippine General Hospital (UP-PGH) has been chosen to lead the clinical trials aimed at looking into the efficacy, safety, and effect on the viral clearance of Ivermectin in asymptomatic and non-severe coronavirus disease (COVID-19) patients.
Dr. Aileen Wang, who spearheads the project, said the clinical trials involve quarantine centers near PGH, the largest COVID-19 referral center in the country.
The veterinary anti-parasitic drug will be tested for efficacy, safety, and effect on 1,464 asymptomatic and non-severe Filipino COVID-19 patients who are at least 18 years old.
The researchers are currently tapping the Philippine Red Cross and local government units for the use of their isolation facilities in Metro Manila.
International and local trials
Wang noted that there are currently 83 ongoing randomized clinical trials for the anti-parasitic drug globally, including in the United States, United Kingdom, and Japan.
"Some studies of IVM have also reported potential anti-inflammatory properties, which have been postulated to be beneficial in people with COVID," Wang said during a virtual briefing.
The Philippine trial, meanwhile, is a double-blind, randomized, controlled trial, where both investigators and participants do not know if the treatment a patient receives is the drug itself or a placebo.
Wang said they are also collaborating with the International Ivermectin Project Team headed by Andrew Hill of the Department of Pharmacology of the University of Liverpool, United Kingdom.
"The objective of the project team is to connect investigators from around the world researching Ivermectin as a treatment for COVID-19. The clinical trials are being evaluated for review and approval by international regulatory bodies," Wang said, adding that the first round of review was already completed by the World Health Organization in March.
Asked if there are also clinical trials to determine if Ivermectin could also prevent and treat COVID-19, Wang said there's no need for the Philippines to conduct such trials.
"Locally, I'm not aware. I'm aware of published on prevention, but these are small studies. I'm aware of at least five prevention studies. I don't think we need to do one in the Philippines, we just need to wait for international studies," Wang added.
In April, President Duterte ordered the Department of Science and Technology (DOST) and the Department of Health to study the use of Ivermectin as a possible treatment against COVID-19.
The DOST said the clinical trials could run for six months.
Registered Ivermectin products are for veterinary use only and are only to treat internal and external parasites and prevention of heartworm disease.
For humans, Ivermectin is available in the Philippines "in topical formulations under prescription use only," according to the Food and Drug Administration (FDA).
Six hospitals in the country have so far been granted a compassionate use permit by the FDA to use human-grade Ivermectin to treat COVID-19 patients.