The clearances for the conduct of the country’s eight month-long Ivermectin clinical trial are expected to be released within this month, the Department of Science and Technology (DOST) said Friday, Jan. 7.
“All clearances are anticipated to be released within January and patient recruitment will commence as soon as all clearances and approvals are obtained,” DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara told the Manila Bulletin in an interview.
The double-blind, placebo-controlled, randomized controlled trial seeks to to assess the efficacy, safety, and effect on viral clearance of anti-parasitic drug Ivermectin in asymptomatic and non-severe coronavirus disease (COVID-19) patients confined in isolation facilities.
Led by Dr. Aileen Wang of the University of the Philippines - Manila, the study will involve 1,464 study participants.
Guevara maintained that the project team has facilitated simultaneous submissions for technical review to University of the Philippines-National Institute of Health (UP-NIH), ethical review to University of the Philippines Manila Research Ethics Board (UPMREB) and Single Joint Research Ethics Board (SJREB), and clinical trial application on the Philippine Food and Drug Administration (FDA) since the second week of November.
She said the UPMREB and SJREB have recommended that the clinical trial protocol be strengthened.
“The project team has received the feedback (comments, and recommendations) from UPMREB and SJREB to further strengthen the protocol and is currently addressing the review queries and clarifications,” the DOST official said.
“The FDA is currently assisting the project team in facilitating the submission of clinical trial requirements,” she added.
READ MORE: https://mb.com.ph/2021/12/02/dost-explains-why-ph-ivermectin-clinical-trial-has-not-yet-started/
Guevara had noted that 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.
She said 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.
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.