Additional clinical trial volunteers for COVID-19 oral pill sought

REUTERS

Quirino Memorial Medical Center (QMMC) has been added as a clinical trial site for molnupiravir, an investigational oral antiviral pill being evaluated for the treatment of coronavirus disease 2019 (COVID-19). Both QMMC and the Lung Center of the Philippines are looking to recruit 10 clinical trial volunteers.

To volunteer, one must

have tested positive for COVID-19 in the past 5 days
have at least one of the following mild to moderate symptoms: cough, sore throat, nasal congestion, runny nose, shortness of breath or difficulty breathing, muscle or body aches, fatigue, fever of at least 38 degrees Celsius, chills, headache, nausea, vomiting, diarrhea, loss of smell, loss of taste
not have been to the hospital due to COVID-19 and does not plan to go to the hospital in the next 48 hours
have at least one characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19: more than 60 years old, active cancer, chronic kidney disease (excluding patients on dialysis), obesity, heart failure, diabetes mellitus, chronic obstructive pulmonary disease
be at least 18 years old
not have been vaccinated by any COVID-19 vaccine

Excluded are those who present severe and critical symptoms such as shortness of breath at rest, heart rate of more than 125 beats per minute, respiratory rate of more than 30 breaths per minute

HOW THE DRUG WORKS
The drug’s mechanism of action is to insert itself in the COVID-19 virus, said Dr. Mary Ann Galang-Escalona, country medical lead, MSD in the Philippines, in a Tuesday webinar. MSD (known as Merck in the United States and Canada) and Miami-based Ridgeback Biotherapeutics developed the drug, which entered Phase 3 clinical trials this June.

“If you’re given it early in the course of the disease,” she said, “it can cause a viral error catastrophe. It’s a phenomenon where the drug inserts itself into the body of the virus. What happens is that all copies of that virus become defective, which means the virus will not cause further severity of the disease for that person.”

The difference between the pill and a vaccine, Dr. Galang-Escalona explained, is that the pill itself will not trigger an antibody response. “It aims to address current infection, but not prevent a future one,” she said.

Those who participate in the clinical trial will be given the trial drug or a placebo to take by mouth every 12 hours for five days.

QMMC’s Dr. Joel M. Santiaguel said volunteers will be monitored via site visits, home visits, and virtual visits for up to seven months. “We’ll be getting blood for testing, performing RT-PCR (real time reverse transcriptase-polymerase chain reaction), and interviewing patients for safety issues,” he said.

“Patients can choose to discontinue the trial at any time for any reason,” added Dr. Virginia S. Delos Reyes of the Lung Center, which started its trial on May 17 and has already completed the trial on 15 patients.

Worldwide, the clinical trial has already reached 50% of its target number of participants. The panelists hope that the drug will be rolled out within the year.

“It will depend on the interim analysis we are submitting to the Food and Drug Administration for the US’s Emergency Use Authorization,” Dr. Galang-Escalona said. “We are hoping for a merry Christmas.”

Those interested in the clinical trial can contact Dr. Virginia S. Delos Reyes at the Lung Center of the Philippines, 0917-899-9610; or Dr. Joel M. Santiaguel at the Quirino Memorial Medical Center, 0917-841-3314. — Patricia B. Mirasol

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