DOST explains why PH Ivermectin clinical trial has not yet started

Published December 2, 2021, 2:36 PM

by Charissa Luci-Atienza 

The Department of Science and Technology (DOST) has explained why the country’s eight month-long clinical trial 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 has not yet begun.

Ivermectin pills (Photo courtesy of IndiaMart via PNA)

DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said necessary preparations were made for the conduct of the study, which will involve 1,464 asymptomatic and non-severe Filipino COVID-19 patients who are at least 18 years old.

“The project team has facilitated simultaneous submission for technical review on UP-NIH (University of the Philippines-National Institute of Health), ethical review on UPMREB (University of the Philippines Manila Research Ethics Board) and SJREB (Single Joint Research Ethics Board) , and clinical trial application on FDA (Food and Drug Administration), since the second week of November (from November 8 to 12),” she told the Manila Bulletin.

The project team is led by Dr. Aileen Wang of the University of the Philippines-Philippine General Hospital (UP-PGH).

Guevara said Wang’s team is currently awaiting feedback from the UP-NIH for the technical review of the research protocol., adding that follow-ups were already done by the project team.

The DOST official noted that the FDA has requested the team to re-submit their application with complete documentary requirements.

“The project team is currently finalizing the said requirements and will submit them as soon as available.”

Guevara also disclosed that ethics approval from UPMREB and SJREB is still pending.

“Other pre-implementation activities such as the Data Trial Management System (DTMS), formulation and compounding of study drugs, and study sites coordination are already arranged and ready once the study commences.”

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.”

READ MORE: http:// https://mb.com.ph/2021/10/17/ph-ivermectin-capsule-to-be-formulated-soon-dost/

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.

The quarantine facilities that have been identified as sites for the clinical trial in Metro Manila are Ateneo Quarantine Facility, La Salle Quarantine Facility, University of the Philippines Diliman (UPD) and Makati Science High School Quarantine Facility.

The project was initially eyed to be implemented by the first week of June this year to January 2022.

READ MORE: http://Drug developers, public to benefit from PH Ivermectin clinical trials ‘if results are good’, says DOST

 
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