AN oral antiviral pill that promises cure for mild and moderate cases of Covid-19 is undergoing clinical trials, which are in need of volunteers.
The Phase 3 global trials of the antiviral drug Molnupiravir, called the MOVe-OUT trial, are ongoing at the Lung Center of the Philippines (LCP) and the Quirino Memorial Medical Center (QMMC) with initial results expected within the year.
Fifteen patients have been enlisted at the Lung Center trial site while recruitment of volunteers is ongoing at Quirino, which is looking for 10 patients.
Dr. Mary Ann Escalona, country medical lead of Merck, Sharp and Dohme in the Philippines, said Molnupiravir is an investigational drug that is not repurposed unlike other drugs used against Covid-19.
Escalona said the drug can prevent the progression of Covid-19 virus in the body five days after symptom onset by inserting itself in the virus' body, causing the copies of the virus to become 'defective,' leading to prevention of further infection or increased severity, especially among persons with comorbidities.
'The importance of this oral antiviral pill once it gets approved, is we wish to have a way to end the spike in the number of cases since we are seeing another surge and we are seeing another trend where hospitals are overburdened with severe cases,' she said in a virtual briefing.
Escalona added that the trials will also look at how the pill may also act against variants of concern including the highly infectious Delta variant of Covid-19.
Dr. Virginia delos Reyes, LCP lead investigator, said patients involved in the clinical trials will be carefully watched and are encouraged to share any side effects they may experience.
'The health care team can alleviate side effects to make the patient comfortable, and the patients will be given standard care if they are randomized whether they receive the placebo or the drug,' delos Reyes added.
To be part of the study, patients must be 18 years old and above, have mild or moderate Covid-19 symptoms and have a comorbidity such as heart disease, chronic kidney disease, chronic respiratory disease and obesity, or the like.
Dr. Joel Santiaguel, lead investigator at the QMMC, said the trials will be up to seven months, and will include home and site visits, blood collection, swab testing and continuous interview of the trial volunteers.
Escalona said once interim data of the trial is published, they will file an emergency use authorization (EUA) with the US Food and Drug Administration and will apply for implementation of the EUA in the Philippines once approval is obtained.