The Department of Science and Technology (DOST) said Sunday, Oct. 31, that the 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 will likely begin on Nov. 15.
DOST Secretary Fortunato “Boy” T. de la Peña said they have to revise the clinical protocol to make it in sync with the international standards as the Philippines became part of an international consortium that has been conducting an analysis of all the randomized Ivermectin clinical trials around the world.
“Hopefully dahil pangalawang postpone na ito, ay November 15 ay maumpisahan na natin. Ang kainaman lang nito ay since maraming lugar ang pagdadausan nito at saka hindi naman ito kamukha ng bakuna na mahaba ang observation kaya ito ay makikita mo agad ang epekto kung gumaling ba o hindi (Hopefully, since these trials were postponed twice, we can begin by November 15. The only good thing about it is that it will be conducted in many areas, and also it is not like vaccines that require long observation period, this one you can see the effect immediately whether it could treat COVID or not),” he said in an interview over DZBB.
De la Peña said the public can expect the release of the project team’s initial report on the clinical trials by end of the year
“Hopefully, end of the year, makapagbigay kami ng first report (we can provide our initial report),” he said.
During the Laging Handa briefing on Oct. 23, DOST Undersecretary for Research and Development (R&D) Rowena Cristina Guevara announced that the recruitment of over 1,400 participants for the Ivermectin clinical trials will begin in November, and that the initial results of the study may be out by end of December this year.
The project team, led by Dr. Aileen Wang of the University of the Philippines-Philippine General Hospital (UP-PGH) is targeting to recruit 1,646 participants for the "double-blind, placebo-controlled, randomized controlled trial", she noted.
Guevara said volunteers may be recruited in Cagayan Valley and Davao should the project team fail to secure the needed number of participants.
Wang’s team partnered with the UP Manila College of Pharmacy for the development of the local Ivermectin capsules that will be used for the clinical trials.
READ MORE: https://mb.com.ph/2021/10/17/ph-ivermectin-capsule-to-be-formulated-soon-dost/
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 had 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.