MANILA (UPDATE) — US-based Merck & Co Inc and Ridgeback Biotherapeutics are recruiting patients in the Philippines for the Phase 3 Clinical Trial of molnupiravir, an oral antiviral treatment for COVID-19.
The Philippines is part of the global study of the experimental antiviral pill, early trials of which showed it could halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.
"If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities," Dr. Nick Kartsonis, senior vice president of Merck's infectious disease unit, said in a statement.
Set to begin this month, the Phase 3 Clinical Trial in the Philippines will take place at the Asian Hospital and Medical Center and Quirino Memorial Medical Center.
The global study, called MOVe-AHEAD, is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the drug makers said.
The trial will enroll approximately 1,332 volunteers who will be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for 5 days.
The study will enroll participants who are at least 18 years of age and currently residing in the same household with someone who received a positive test for SARS-CoV-2, has at least 1 sign or symptom of COVID-19 and has not had those signs and symptoms for more than 5 days.
The drugmakers said volunteers were not eligible for the trial if they had received the first dose of a COVID-19 vaccine more than 7 days prior to enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19.
Those who wish to participate or health care professionals who would like to refer patients may call or text the Asian Hospital and Medical Center at 0968 558 3091 or 0927 007 6602, or the Quirino Memorial Medical Center at 0917-841-3314.
COMPASSIONATE SPECIAL PERMIT
The first shipment of the potentially game-changing COVID-19 antiviral pill arrived in the Philippines last week, the first delivery of the drug in Southeast Asia.
The Food and Drug Administration has issued a compassionate special permit for use of molnupiravir in several hospitals.
In early November, Britain became the first country in the world to approve molnupiravir to boost its fight against the pandemic.
According to an interim analysis, molnupiravir cut the rate of hospitalization and death by 50 percent in a trial of mild-to-moderately ill COVID-19 patients who had at least one risk factor for the disease.
The pill would be the world's first oral antiviral medication for COVID-19 if it gets regulatory approval.
In the Philippines, the experimental COVID-19 pill is also available to patients of the telemedicine program of Vice President Leni Robredo's office and in Sta. Ana hospital in Manila, as announced by Mayor Isko Moreno-Domagoso's office.
Under the agreement, the OVP will issue a guarantee letter under its special medical assistance program to any qualified patient referred by a volunteer doctor in the OVP's Bayanihan E-Konsulta. The patient will be further assessed and prescribed molnupiravir by QualiMed facilities.
Moreno meanwhile said it has a deal with Faberco, which made Molnupiravir (Molnarz) available in the Philippines through Compassionate Special Permit (CSP) issued by the Food and Drug Administration.
Infectious disease expert however called on the public to be careful in using molnupiravir.
"Long-term use has mutagenic potential. It is currently only for high-risk populations with confirmed mild/moderate COVID infection under compassionate use and only for 5 days," Dr. Edsel Salvaña wrote on Facebook Tuesday.
He said the risk-benefit ratio of monupiravir was still "uncertain."
"If you have severe COVID, it doesn't really work and other meds need to be used. Never take any meds without proper medical consultation. Stay safe," added Salvaña, also a member of the Department of Health’s Technical Advisory Group.