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Recruitment of melatonin trial participants still ongoing - DOST
Recruitment of melatonin trial participants still ongoing - DOST
The recruitment of participants for clinical trial on the use of sleep-aid supplement melatonin as adjuvant treatment for coronavirus disease (COVID-19) in patients with pneumonia is ongoing, the Department of Science and Technology (DOST) has disclosed.
DOST Secretary Fortunato “Boy” T. de la Peña said the melatonin clinical trial is headed by Dr. Camilo C. Roa Jr. of the Manila Doctors Hospital and is implemented for nine months, from Sept. 7, 2020 to June 6, 2021.
"Currently, recruitment of participants is ongoing,” he said.
He said the project has already started the recruitment in 12 out of the 17 hospital sites.
Aside from the Manila Doctors Hospital (MDH), Dr. Jose Rodriguez Memorial Center (DJRMC), The Medical City (TMC), San Lazaro Hospital (SLH), Lung Center of the Philippines, San Juan de Dios Hospital (SJDD), Cardinal Santos Medical Center, Philippine Heart Center (PHC), Makati Medical Center, East Avenue Medical Center, Manila Medical Center, and Vicente Sotto Memorial Hospital were also involved in the melatonin clinical trial
De la Peña said of the 350 targeted participants, 61 have already been enrolled in the trial. Of the enrolled participants, 14 were from DJRMC, 13 from MDH, seven from TMC, 10 SLH, two from PHC, eight from Makati Medical Center, five Manila Medical Center, and two from SJDD.
"Initial analysis will be done once 50 percent of the target participants have been reached,” he said.
De la Peña said the project is a randomized, double-blind, placebo-controlled trial which seeks to determine whether administering high doses of melatonin (hdM) will lessen the need for intubation or ventilation support of hospitalized COVID-19 patients and ultimately improve the survival rate against the infection.
"The study aims to determine the effectiveness or efficacy (improvement of survival, less need for intubation and mechanical ventilation, clinical improvement and recovery) and safety of hdM (100 milligrams p.o. (one tablet by mouth) initially then three to four mg/KBW (kilogram body weight)/day p.o. in four divided doses) as adjuvant therapy on top of standard or empirical therapy in hospitalized patients with COVID-19 pneumonia,” he said.