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Ivermectin clinical trial protocol being drawn up
Undated photo of Ivermictin capsules.
Interaksyon/FDA/Released

Ivermectin clinical trial protocol being drawn up

Rainier Allan Ronda (The Philippine Star) - May 4, 2021 - 12:00am

MANILA, Philippines — The University of the Philippines-Manila team that will conduct clinical trials on Ivermectin as a cure for COVID-19 is formulating the research protocol for the study, an official of the Department of Science and Technology (DOST) said yesterday.

Jaime Montoya, executive director of the DOST-Philippine Council for Health Research and Development, said the UP-Manila team would submit its protocol or design of the clinical trial for approval by the department and the Food and Drug Administration (FDA).

He added that DOST expects the team, headed by Dr. Aileen David Wang, to start the clinical trials as early as this month.

The Ivermectin to be used in the trial is in tablet form and could be sourced from a local manufacturer, which should be able to get a permit from the FDA. If the local manufacturer will not be able to secure FDA approval in time for the start of the UP-Manila clinical trial, Montoya said they could just import the supply abroad.

He noted that the clinical trial will include non-severe – mild to moderate – cases of COVID-19 on both symptomatic and asymptomatic patients as commonly found in quarantine facilities.

Montoya said at yesterday’s Laging Handa briefing that the data gathering on Ivermectin’s efficacy against COVID-19 in a clinical trial will be more useful if the study will cover non-severe cases.

The clinical trial, he added, will also tap the cooperation of the Philippine Red Cross as it will target to get volunteers from the PRC’s quarantine facilities.

Montoya is hopeful that the clinical trial will be completed by the end of the year and the data, which have to be studied and analyzed, available by the first quarter of 2022.

This timetable, though, can still be shortened if many patients would volunteer for the trial.

Meanwhile, Health Undersecretary Maria Rosario Vergeire said at yesterday’s press briefing that a parallel investigation on the mass distribution of Ivermectin in Quezon City last week will be conducted by the Professional Regulation Commission (PRC) and the FDA.

She revealed that the DOH wrote the PRC last Friday to look into reports on the issuance of “invalid prescription” for Ivermectin by doctors who joined the mass distribution.

Vergeire said they want to know from the PRC the “practice of profession” of the doctors who took part in the activities. To date, only five undisclosed private hospitals have been given the compassionate special permit (CSP) that allows their doctors to prescribe Ivermectin to their patients.

At a separate briefing, FDA director general Eric Domingo has given assurance that they would hold accountable those behind the mass distribution spearheaded by Anakalusugan party-list Rep. Mike Defensor and Sagip party-list Rep. Rodante Marcoleta.

“We treat each report we receive as a complaint that we have to investigate. Our regulatory enforcement unit is already investigating these complaints,” Domingo said.

He underscored that the FDA will look into the process during the event, “if they followed the regulations, if they are licensed manufacturers and distributors, (and if there) were violations.”

“There will be appropriate sanctions and penalties,” Domingo added. – Sheila Crisostomo

DEPARTMENT OF SCIENCE AND TECHNOLOGY FDA IVERMECTIN
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