DOST-PCHRD presents updates on clinical trials of potential treatment and adjunctive therapy for COVID-19
DEPARTMENT OF SCIENCE AND TECHNOLOGY
Week 58 Report (as of May 7, 2021)
by Enrico Belga Jr.
The DOST-Philippine Council for Health Research and Development (PCHRD) reports on the status of ongoing clinical trials for the use of virgin coconut oil, lagundi, tawa-tawa, and melatonin as potential treatment and adjunctive therapy for COVID-19. These projects received funding support from DOST-PCHRD and are being implemented by partner research institutions and various hospitals.
This project aims to determine the safety and efficacy of Virgin Coconut Oil (VCO) as adjunctive therapy for COVID cases in the Philippine General Hospital (PGH). Specifically, it aims to determine the safety of VCO through clinical parameters such as lipid profile, fasting blood sugar (FBS) and creatinine and the efficacy of VCO through recovery from symptoms and virus clearance. The project started its implementation on June 1, 2020.
Currently, the project team has screened 832 patients wherein 42 were enrolled to the study. Out of the 42 enrollees, 20 patients were under the VCO group while 22 received only the standard care. The project team plans to conduct an interim analysis to serve as basis for further studies on the mechanism of action of VCO.
The project is a randomized, parallel 2 stage clinical trial to determine if Lagundi (NIRPROMP Formulation) can provide symptomatic relief for COVID-19 patients as well as determine if it can decrease the number of patients who progress from mild disease to moderate or severe disease.
Screening and recruitment of participants for stage 1 and stage 2 are already completed. The project has enrolled 278 participants from seven (7) quarantine facilities. The preliminary result in stage 1 shows that Lagundi was well tolerated for both high dose (1.2g 3x a day) and normal dose (600mg 3x a day). Further, very few patients experienced mild adverse drug reactions, and no patient became moderate or severe COVID-19 case.
Based on the primary outcome measures and safety from stage 1, the normal dose (600mg 3x a day) is more effective than the high dose (1.2g 3x a day). Hence, the normal dose was used in Stage 2 to compare to the placebo. Currently, the project team continues to follow-up and monitor the last enrolled patients, and then they will start the data analysis for stage 2 by next week.
The Memorandum of Agreement (MOA) between University of the Philippines Visayas and Corazon Locsin Memorial Hospital was signed. The recruitment, enrollment and initial assessment of prospective patients for the project has started.
An initiative on the use of melatonin as an adjuvant treatment for COVID-19 patients with pneumonia is being implemented by the Manila Doctors Hospital. The project is a randomized, double-blind, placebo-controlled trial which 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 mg p.o. initially then 3-4 mg/KBW/day p.o. in 4 divided doses) as adjuvant therapy on top of standard or empirical therapy in hospitalized patients with COVID-19 pneumonia.
Currently, recruitment of participants is ongoing. The project has already started the recruitment in 12/17 hospital sites (Manila Doctors Hospital, Dr. Jose Rodriguez Memorial Center, The Medical City, San Lazaro Hospital, Lung Center of the Philippines, San Juan de Dios Hospital, Cardinal Santos Medical Center, Philippine Heart Center, Makati Medical Center, East Avenue Medical Center, Manila Medical Center, and Vicente Sotto Memorial Hospital). 61/350 participants have already been enrolled in the trial (14 from DJRMC, 13 from MDH, 7 from TMC, 10 SLH, 2 from PHC, 8 from Makati MC, 5 Manila MC, 2 from SJDD). Initial analysis will be done once 50% of the target participants have been reached.
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