Lung Center part of Phase 3 clinical trial for Molnupiravir vs COVID-19

ABS-CBN News

Posted at Aug 26 2021 11:26 AM | Updated as of Aug 26 2021 11:42 AM

MANILA - Two government hospitals in the Philippines, including the Lung Center of the Philippines, are currently involved in the phase 3 global trials of an oral antiviral pill that shows promising results to treat mild and moderate COVID-19 cases.

Dr. Randy Castillo, division head and also head of the COVID-19 Triage Task Force of the LCP, said Thursday the Philippines is among other countries around the world, including the US, Canada and Japan, that are participating in the clinical trial of Molnupiravir among 1,800 individuals.

Speaking to ABS-CBN's TeleRadyo, Castillo said they started with the clinical trial last May, with a target population of 30. He said they already requested for an additional medicine last week as this really prevents the disease from progressing to severe or critical.

“Ito ay kapsula na kasalukuyan ay nakitaan ng magandang epekto upang makatulong sa pagsugpo ng COVID-19, na sanhi nitong COVID-19 infection. Ito ay gumagana sa pamamagitan ng paghinto ng pagreplika o pagdami ng virus sa ating katawan. At usually, ibinibigay namin ito sa mga pasyenteng may mild to moderate disease. Iiwasan natin na lumala pa at maging severe to critical,” Castillo said.

(This capsule shows good effects in fighting COVID-19. This works by preventing the replication of the virus in the body. It is usually given to patients with mild to moderate diseases. We will try to prevent the disease from becoming severe to critical.)

Aside from the LCP, also engaged in the trial is the Quirino Memorial Medical Center. He said recruitment for both hospitals will be until September.

“Ito ay clinical trial. Ito ay ginagawa rin sa ibang bansa para malaman kung itong gamot na ito ay magiging available sa merkado. Ngayon, nasa phase 3 na siya. Dumaan ito sa Phase 1 at Phase 2. Nakitaan sa dalawang phases na ito na talagang safe itong gamot at malaki ang potential para makatulong sa pagsugpo ng virus,” Castillo said.

(The clinical trial is also being done in other countries to determine if this medicine will be made available in the market. Now, this is on Phase 3 after going through Phases 1 and 2. In the first two phases, it showed that it's safe and the medicine has big potential to help fight the virus.)

Castillo said patients must first give their consent before joining the clinical trial, and must pass the inclusion and exclusion criteria. These include COVID-19 symptoms that the patient is experiencing within 5 days as the medicine shows potential when given at the early stage of the disease.

“Tapos hindi rin nabakunahan ang pasyente ng COVID vaccination. Yun ang pinipili nating subset ng population ng mga indibidwal na isasali. Dapat merong din silang isang kondisyon na maaring magdulot ng paglala kasama na d'yan yung edad mahigit 60 taong gulang, may aktibong cancer, COPD, chronic kidney disease na hindi nagda-diaylsis, obesity o yung BMI mahigit 30, diabetes, at sakit sa puso. Kapag na-fulfill ng pasyente itong mga inclusion criteria na ito ay maaari silang sumali dito sa trial na ito,” he said.

(They should be unvaccinated against COVID-19. That’s the subset population of individuals joining the trial. They also must have one condition or comorbidity like more than 60 years old, with active cancer, COPD, chronic kidney disease without dialysis, obesity and heart problems. Once a patient fulfills these inclusion criteria, they may join the trial.)

The medicine is given twice a day at 800mg for 5 days. Castillo said an appealing feature of the trial is that doctors and nurses can go to the patients' house to monitor them. The goal, he said, is for the patient to not be admitted in the hospital but treated at the comfort of their homes.

“Pitong buwan ang magiging observation period namin sa mga pasyenteng ito. Limang araw lang paiinumin, pero aabutin ito ng 7 buwan para sigurado tayo na walang problema at makita natin ang mga potensiyal na mangyayari sa pasyente,” he said.

(The observation period is for 7 months. We will give the medicine for 5 days but we will observe them for 7 months.)

Castillo said the phase 3 global trial will be completed around September to October this year.
 
“Inaasahan natin na nagkakaroon na ng interim analysis itong mga imbestigador regarding dito. At ang next step niya, basta makakitaan na maganda itong gamot ay magkakaroon na ito ng rekomendasyon para ma-approve ng US FDA. At kapag napayagan ng US FDA, doon na mag-aapply ng EUA itong mga iba’t ibang bansa para maging available na siya maski dito sa Pilipinas,” he said.

(We expect investigators to already conduct interim analysis on this trial. The next step is to get the recommendation and approval of the US Food and Drug Administration. Once that is done, countries may now apply for emergency use authorization to make the medicine available even in the Philippines.)

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