By Maria Isabel Gallego and Alain Kyle Robredillo
Health experts see the oral antiviral drug Molnupiravir as a promising treatment against mild to moderate infections of COVID-19 and have called for volunteers to reach the target number of patients for its global clinical trials.
The Lung Center of the Philippines (LCP) initiated its clinical trials last May 17 with 11 COVID-19 patient-volunteers, while the Quirino Memorial Medical Center (QMMC) recently participated and both hospitals will be expected to resume its recruitment pause within the week.
The Philippines is part of 100 countries that underwent global clinical trials to test the effectiveness of Molnupiravir.
“We have already reached 50 percent of the total number of participants, perhaps even greater than 50 percent. So, that’s the latest update from our global clinical trial team,” Dr. Maan Escalona, Merck Sharp & Dohme (MSD) country medical lead, said.
During the clinical trial, mild to moderate COVID-19 patients will be asked to orally take Molnupiravir twice a day for five days.
The drug, according to initial studies, has shown no signs of major adverse effects during its clinical trials, and has manifested positive results such as improvement of the patient and reduction of viral load.
However, since it is still an on-going study, COVID experts expect other health effects on the clinical trial volunteers.
“The study is still ongoing so we cannot really say definitively the number of adverse effects, but at least on our side there is no major side effect and it’s really an on-going trial, so we have to look at it to the end. But in the previous, earlier trials for Molnupiravir it shows that it is safe,” Dr. Virgina Delos Reyes, LCP’s clinical trial investigator, said.
Interim analysis has yet to be conducted to see if the effect of Molnupiravir was common for all of the types of the COVID-19 variant, which is not the “primary end-point” according to Escalona.
“The primary objective of the study is to see whether we’d see an improvement in the patient (and) decrease in the viral load. We still have to see whether there would be some equal benefit across the different variants,” Escalona said.
“It’s not like a vaccine that can address future infections. The pill itself will not trigger any bodily response. So, it will address the current infection.”
Escalona added MSD is hoping for Molnupiravir to be approved in the country so it can begin its rollout before the end of the year.
If approved, the drug will not be available over the counter.
“As for the cost we still do not have visibility as to how much Molnupiravir will cost. But that will depend on the type of country, the economic status of the country,” Escalona said.
With the hope of having a successful trial for Molnupiravir against mild and moderate cases of COVID-19, Dr. Joey Santiaguel, clinical trial investigator from Quirino Memorial Medical Center, asked for more volunteer patients for their clinical trials.
“We are just starting, if you know anyone or have a potential patient you think can benefit from this medication for this clinical trial you can refer it to us,” Santiaguel said.
“We have already achieved the 16 participants that we initially targeted, but we ask for 10 more additional patients,” Delos Reyes added.
Dr. Loysa Orense, Bantay Covid Quezon City representative, listed the specifications of the patients who can qualify for the clinical trials for Molnupiravir. They are:
Experiencing at least one of the following COVID-19 symptoms — cough, sore throat, nasal congestion, runny nose, shortness of breath or difficulty in breathing, fatigue, muscle or body aches, fever of 38.0 degrees Celsius or higher, chills, headache, and other symptoms.
Has at least one characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
Age 60 and younger.
Includes only mild and moderate COVID-19.
Escalona added the participants in the clinical trials were conducted among non-vaccinated individuals.
“Once you are vaccinated, you are excluded in the clinical trial, we won’t be able to tell whether there is a difference between the vaccinated and non-vaccinated because all the participants are non-vaccinated,” she said.
Most of the patients who enlisted for the clinical trials are either referred by other doctors or personally volunteered, the experts added.
As the clinical trial is still ongoing, LCP and QMMC officials assure that volunteer patients are regularly visited, checked, and are given utmost care while they are participating.
“Our goal is for this mild to moderate patient to not to progress to severe, hindi sila ma-ospital,” Escalona added.
For those who wish to participate, you may contact Dr. Delos Reyes of the Lung Center of the Philippines at 0917-899-9610 and Dr. Santiaguel of Quirino Memorial Medical Center at 0917-841-3314.