7th DOH Steering Committee Meeting for the Clinical Trials on COVID-19
Today, the DOH Steering Committee for the Conduct of Clinical Trials for investigational treatment for COVID-19 convenes to discuss updates regarding the clinical trials for investigational products (IPs) for COVID-19.
Undersecrertary Maria Rosario Vergeire of the Health Regulation Team presided the 7th meeting via Zoom interface. The status of the WHO Solidarity trials for COVID-19 treatments and vaccines were presented by WHO Philippines. There are 30 countries participating in the Solidarity Trial for treatments including the Philippines wherein three (3) treatment arms are currently being used, i.e., Remdesivir, Interferon and local standard of care (SoC), while two (2) treamtent arms were discontinued, i.e., Hydroxychloroquine and Lopinavir/Ritonavir. Most recent results reveal that there is no significant difference in the mortality rates using the four treatment arms apart from the local Standard of Care. More additional treatment arms, e.g., Aclabrutinib and monoclonal antibodies shall be included in the trial to prove its effectiveness in combating COVID-19.
On the other hand, preparations for the conduct of the Solidarity Trial for vaccines which is expected to commence by the end of October 2020 is under way, taking into consideration the storage requirements. Some of the IPs shall need ultra freezer requiring temperatures ranging from -40˚C down to -86˚C. Further, the DOH and DOST are jointly studying the logistics management of the vaccines. It is hoped that the vaccine Solidarity Trial shall carry forward as planned.
One of the topics that was discussed on the 7th Steering Committee Meeting
Another trial that is being overseen is the Favipiravir (Avigan) trial, which is subject for protocol amendment. The said trial, which commenced on October 12, 2020, is currently employing 96 patients in four (4) study sites. The inclusion criteria may be modified to shift from moderate to mild COVID-19.
Other updates include the nomination of the members of the Data Safety Monitoring Committee (DSMC) by the Steering Committee members, composition of the National Coordinating Committee, recommendations on how the DOH can determine if a clinical trial for COVID-19 is worth pursuing, proposed funding for DOH-sponsored clinical trials, and introduction of a new antiviral drug which is being proposed to undergo clinical trial.
The DOH National Steering Committee was established to ensure the necessary oversight in the administration of investigational therapies for COVID-19 patients and ensure their safety and well-being (DPO No. 2020-1377). The matters being discussed are crucial considering the need for approved treatments that will be effective to manage the COVID-19 infection. The Steering Committee shall continue to hold meetings until its tasks in the conduct of clinical trials for COVID-19 are completed
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