The Department of Science and Technology (DOST) said the “latest protocol" for the country’s eight month-long 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 “is now for ethics review.”
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said after the ethics review, the protocol will be submitted to the Food and Drug Administration (FDA) for its approval.
“Latest protocol is now for ethics review after which will be submitted to FDA for clinical trial approval. Recruitment and patient-in will proceed after obtaining clinical trial clearance,” she told the Manila Bulletin in a Viber message.
The DOST announced last month that the recruitment of 1,464 Ivermectin trial participants may start in November, and that the initial results of the study may be out by end of December this year.
READ MORE: https://mb.com.ph/2021/10/23/recruitment-of-1464-ivermectin-trial-participants-to-start-in-november/
https://mb.com.ph/2021/10/31/dost-eyes-ph-ivermectin-clinical-trials-to-start-on-nov-15/
Guevara cited that resources and tools for the clinical trial were ready, including the study drug compounding, the digital trial management suite (DTMS), and the creation of the data safety monitoring committee (DMSC).
“Compounding of the study drug is ready. They will produce the capsules after FDA approval. Production of the capsules will take a very short time.”
The DOST- Philippine Council for Health Research and Development (PCHRD) said in preparation for the 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 which 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.
Guevara said the clinical trial sites are currently preparing for the initiation activities.
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.