Duterte allocates funds for clinical trials on melatonin for treatment of COVID-19 patients

Published June 16, 2020, 12:00 AM

by manilabulletin_admin

By Genalyn Kabiling

The government will press ahead with the clinical trials on the use of high-dose melatonin as potential supplementary treatment for coronavirus patients.

In his latest report to Congress, President Duterte said the Department of Science and Technology (DOST) has approved a P9.8 million project for the conduct of clinical trials of the efficacy of melatonin.

President Rodrigo Roa Duterte reviews a document during a meeting with members of the Inter-Agency Task Force on the Emerging Infectious Diseases (IATF-EID) at the Malago Clubhouse in Malacañang on June 15, 2020. ROBINSON NIÑAL JR./PRESIDENTIAL PHOTO
President Rodrigo Roa Duterte reviews a document during a meeting with members of the Inter-Agency Task Force on the Emerging Infectious Diseases (IATF-EID) at the Malago Clubhouse in Malacañang on June 15, 2020. (ROBINSON NIÑAL JR./PRESIDENTIAL PHOTO / MANILA BULLETIN)

He said melatonin will be tested as “adjuvant or supplementary treatment for COVID-19 patients with pneumonia.” Melatonin is an over-the-counter drug that helps ease sleep disorders.

“Initial studies have shown that melatonin improved outcomes in patients admitted to the Manila Doctors Hospital with COVID-19 pneumonia and high-risk features,” Duterte said.

He said a team from the Manila Doctors Hospital (MDH) headed by Dr. Rafael Castillo will conduct the project for four months. At least 350 patients will take part in the trials.

“Results of the project are expected to contribute to national and international guidelines on life-saving drugs and therapy that can impact mortality in COVID-19 pneumonia patients,” Duterte said.

He noted that melatonin is a “safe, commonly available and affordable supplement worldwide.”

As of June 10, the President also noted that there are 260 patients from 24 hospitals are participating in the World Health Organization Solidarity Trials for the potential coronavirus vaccine.

Medical research on melatonin and COVID-19

A team of Filipino physicians and American scientists published the first report on the use of high dose melatonin in patients afflicted with coronavirus disease 2019 (COVID-19) pneumonia.

After a stringent peer-review process, the pilot case series paper entitled Melatonin as Adjuvant Treatment for Covid-19 Pneumonia Patients Requiring Hospitalization (MAC19 PRO) was published in the June 15, 2020 issue of Melatonin Research Journal in the United States. It was a special issue of the journal dedicated to COVID-19.

A more extensive trial is now about to be started, funded by the Department of Science-Philippine Council for Health Research and Development (DOST-PCHRD) to validate the favorable observations on the effect of high dose melatonin in COVID-19 patients, as shown in the pilot study, which also received funding assistance from DOST-PCHRD.

“We are aiming to build on the use of melatonin as a commonly available supplement to support our fight against Covid-19,” says Dr. Jaime Montoya, DOST-PCHRD executive director. “If the project proves to be successful, we may be able to de-escalate Covid-19 cases better, and possibly reduce the mortality rate of the infection.”

In the published study of patients admitted to the Manila Doctors Hospital (MDH) between March 5, 2020 to April 4, 2020, clinical stabilization and/or improvement was noted within four to five days after initiation of high dose melatonin. All 10 patients on high dose melatonin survived—including three with moderately severe acute respiratory distress syndrome (ARDS), a life-threatening complication of COVID-19 in the lungs which has been implicated as a major cause of death.

To provide perspective, although the patient groups were not comparable, 12 of the 34 COVID-19 positive patients (35.3 percent) who were not given melatonin died; seven of 34 (20.6 percent) required hooking to a respirator or mechanical ventilator to assist the patient’s breathing.

No significant side-effects were noted with high dose melatonin except for sleepiness, which was deemed favorable by all patients, most of whom had anxiety- and symptom-related sleeping problems previously.

The authors, headed by MDH consultant Dr. Rafael Castillo, concluded that “high dose melatonin may have a beneficial role in patients treated for COVID-19 pneumonia, in terms of shorter time to clinical improvement, less need for intubation and mechanical ventilation, shorter hospital stay, and possibly lower death rate.”

However, Castillo cautioned that this was only a descriptive and observational study, and no definite conclusions can be derived from it; hence, the need for the expanded randomized, double-blind, placebo-controlled study, which the group hopes to complete and publish by November of this year.

MDH is the lead hospital in the study, but other COVID-19 designated government and private hospitals will also be tapped in this multicenter clinical trial aiming for 350 patients randomized to high dose melatonin plus standard care, or placebo plus standard care.

Aside from Castillo, coauthors in the MAC19 PRO pilot case series include Doctors Gino Rei Quizon (co-principal investigator), Dante Morales, Mario Joselito Juco, Arthur Dessi Roman, Donnah de Leon, Felix Eduardo Punzalan, Rafael Bien Guingon, Dun-Xian Tan, and Russel Reiter.

Professors Reiter and Tan are world renowned researchers from the University of Texas in the US, and are among the highly cited scientists in the prestigious Thomson Reuters and Clarivate Analytics lists. They have a combined track record of more than 70 years in melatonin bio-cellular research.

In the MAC19 PRO randomized clinical trial, they are joined by Professors Gregory Brown from University of Toronto, David Streiner from the McMaster University, Harold Pupko from the North York Clinical Practice, all in Canada; Bernadette Tumanan-Mendoza, Noemi Pestano and Jundelle Romulo Jalique from Manila Doctors Hospital; and Camilo Roa, Jr., from the University of the Philippines-Philippine General Hospital.

Health facilities

In the 12th weekly report to Congress, the President gave a rundown on the status of country’s health facilities and resources.

He said the country’s COVID beds have so far reached 13,794 with an occupancy rate of 33.9 percent. At least 79.7 percent of the 2,015 mechanical ventilators are available.

Seven of the 11 mega community quarantine facilities in Metro Manila and nearby cities are in operation. The remaining facilities have been completed and are ready to be turned over for operations.

As of June 12, 80 out of 129 converted regional evacuation centers are being used as health and quarantine facilities, emergency operation centers, food hubs and quarters for health workers.

He said the floating ships from 2GO Shipping Lines have been demobilized while the Eva Macapagal Super Terminal COVID-19 treatment facility is being used for quarantined overseas Filipino workers.

As of June 10, the Bureau of Quarantine manages 44 quarantine facilities, including 17 hotels and 27 cruise ships. At least 48,150 returning overseas Filipinos have been released from quarantine facilities while 10,693 are still undergoing quarantine.

Testing efforts

As of June 10, Duterte said 473,281 tests have been conducted on 436,448 persons. The daily average number of tests processed is 10,771.

He said the country’s testing capacity is “steadily increasing’ with the accretion of 58 testing laboratories. As of June 11, 151 laboratories are being evaluated.

The Food and Drugs Administration has also so far approved 158 tests kits for the coronavirus.

Contact tracing

The President also addressed the concerns on the reliability of the contact tracing application StaySafe.ph in his report to Congress.

He said the Department of Information and Communications Technology (DICT) has reviewed the submission of Multisys Technologies Corporation on vulnerability assessment and penetration testing, private impact assessment, and software, data governance and operational plan before encoring the use of the application.

Also, Duterte said the Department of Science and Technology has started using the SafePass system in two government facilities. He said SafePass is an all-digital, contact-free authorization, scheduling and contract tracing solution to help offices and business operatively safely amid the pandemic.

“It can be used to plan and manage space capacity and people’s schedules to allow safe distancing during operation hours, ” he said.

Medical equipment

Of the 255 local and donations of medical equipment and supplies, Duterte said 173 have been completed and delivered. The donations include 4,873,950 surgical masks, 101 ventilators, 378,480 N95 masks, and 242,279 personal protective equipment/medical coveralls.

The country has received 1,632,248 RT-PCR testing kits from donations, Duterte said.