Bracing for “good results,” the Department of Science and Technology (DOST) said Thursday, Oct. 21, that the drug developers and the public are expected to benefit from the country’s clinical trials seeking to assess the efficacy, safety, and effect on viral clearance of anti-parasitic drug Ivermectin in asymptomatic and mild coronavirus disease (COVID-19) patients confined in isolation facilities.
DOST Undersecretary for Research and Development (R&D) Rowena Cristina Guevara said if the results of the local clinical trials are good, the drug developers and the public will benefit from it.
“The use of Ivermectin as medication for COVID-19 became a public clamor for the past months despite insufficient scientific evidence, if the results of this study is good, then the drug developers can use the results of the study for guidance on how to use ivermectin. Eventually, benefitting the public,” she said in a statement.
The DOST official announced on Sunday, Oct. 17, that the Philippines will produce its own Ivermectin capsule.
The DOST- Philippine Council for Health Research and Development (PCHRD) said in preparation for the eight month-long project, the project team, led by Dr. Aileen Wang of the University of the Philippines-Philippine General Hospital (UP-PGH) partnered with the UP Manila College of Pharmacy “who can develop and compound the local Ivermectin capsules easily in a short period of time.”
“The project is working with its own formulation to comply with the existing standards for double-blind, placebo-controlled trials.”
Guevara explained that the project team will formulate their own capsules “because the trials require the placebo and the active drug to look the same to avoid patient and physician bias.”
The partnership between Wang’s project team and the UP Manila College of Pharmacy was aimed at standardizing the study drugs to be used — placebo and active drug, in the local clinical trials.
“We would like to reiterate that the compounded capsules to be used solely for the purpose of clinical trials will adhere to Good Manufacturing Practice and Compounding Practice, and will be subjected to tests for raw materials and finished product,” said Dr. Yolanda Robles, lead of the Pharmacy team of the ivermectin trials.
The DOST-PCHRD noted that currently, there are 75 registered clinical trials on the use of Ivermectin as COVID-19 treatment around the world.
“We assure the public that our ultimate goal in the Philippine Council for Health Research and Development (PCHRD) is to provide them with solutions backed by scientific evidence,” said PCHRD Executive Director Jaime C. Montoya.
The Department of Health (DOH) and the Food and Drug Administration (FDA) are not yet recommending the use of Ivermectin for the treatment of COVID-19 due to insufficient scientific evidence.
The quarantine facilities that have been identified as sites for the clinical trials in Metro Manila are Ateneo Quarantine Facility, La Salle Quarantine Facility, University of the Philippines Diliman (UPD) and Makati Science High School Quarantine Facility.
A total of 1,464 asymptomatic and non-severe Filipino COVID-19 patients who are at least 18 years old will be involved in the study.
The study aims to provide data on the efficacy, safety, and effect on the viral clearance of Ivermectin among asymptomatic and non-severe Filipino patients.
The project was initially eyed to be implemented by the first week of June this year to January 2022.
The DOST earlier said the interim analysis report on the trials may be out by mid-December. It explained that the changes to clinical trial protocols have delayed the start of the study.
The government has allocated P22 million for the conduct of the Ivermectin clinical trials.