The Department of Health (DOH) with the Food and Drug Administration (FDA), in the July 1 Beat COVID-19 Virtual Presser released critical updates on the ongoing COVID-19 trials as part of the World Health Organization’s (WHO) Solidarity Trial for treatments. The global clinical trial aims to rapidly discover treatment options to help find an effective treatment for COVID-19.

“Ang pagtuklas ng lunas laban sa COVID-19 ay napakahalaga. Ang pangangasiwa ng mga inisyatibo ukol sa mga bakuna o ang mga pagsisikap na makatuklas ng lunas ay kasing halaga upang masiguro ang kaligtasan at proteksyon ng bawat Pilipino at ng buong mundo,” said Health OIC-Undersecretary Maria Rosario Singh-Vergeire, underscoring the importance of thorough, strict and oversight regulation on clinical trials.

The Health Spokesperson was joined by FDA Director General Rolando Enrique Domingo who gave an overview on the current trials being done. “Sa kasalukuyan ay mayroong 17 candidates para sa COVID-19 vaccines na nasa clinical trial stage at 132 candidate vaccines naman ang nasa pre-clinical evaluation. Ang FDA ay mayroon nang koordinasyon sa Department of Science and Technology para sa technical review ng mga mag-a-apply ng COVID-19 vaccine clinical trial sa bansa,” Domingo said.

In the virtual presser, drugs such as hydroxychloroquine, remdesevir, lopinavir with ritonavir, and lopinavir with ritonavir plus interferon beta-1a were mentioned as part of the WHO Solidarity Trial. The Philippines currently has 450 patients enrolled in 22 active sites under the program.

Director General Domingo elaborated on hydroxycholoroquine which he explained had long been registered in the Philippines for patients with rheumatic diseases and lupus. The drug used to be part of the Solidarity Trial but was recently stopped due to evidence that it does not minimize COVID-19’s mortality rate.

Remdesevir, originally meant for Ebola Virus, is now being administered to COVID-19 patients. It has been reported that in some clinical trials, remdesevir helped shorten the recovery time of some patients. “Isa ito sa mga bagong gamot kaya wala pa itong aprubadong indikasyon at Certificate of Product Registration sa kahit na anong bansa. Kaya ang mga bansang gumagamit ng remdesivir ay may mga limitasyon sa paggamit nito gaya ng pag-enroll sa clinical trials,” explained Domingo.

Domingo also reported on dexamethasone which is used to treat allergy and low blood pressure of hospitalized patients. He further reminded the public when he said, “mahigpit na pinaaalahanan ng FDA ang publiko na hindi ito iniinom kung walang indikasyon. Kailangan ang reseta at pagsubaybay ng isang doktor sa paggamit nito.”

While dexamethasone is not part of the WHO Solidarity Trial, data from the United Kingdom recently reported that the drug has helped in lowering the mortality rate of COVID-19 patients who are in critical condition. However, Domingo stressed that although early data shows promising results on the efficacy of dexamethasone in treating COVID-19, it must not be used for self-medication as it could have severe side effects to healthy individuals.

Drugs, such as remdesivir which have stricter limitations as to use, may be administered to patients under emergency use. Domingo reported that as of June 30, there are 40 drug applications approved in the Drugs for Emergency Use (DEU). The FDA also recently released FDA Circular No. 2020-012 or “Guidelines for the registration of drug products under emergency use (DEU) for the coronavirus disease 2019 (COVID-19)” which aims to provide streamlined requirements and application process for the registration of drug products under emergency use for COVID-19. The circular covers all marketing authorization holders that will manufacture and import or distribute the drug products indicated in the Philippine Society for Microbiology and Infectious Diseases Interim Guidelines on the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection.

The FDA Director General also warned against the deliberate selling of unregistered drugs. Domingo reported, “Sa kasamaang palad kahit sa panahon ng pandemya, mayroong mga taong nagsasamantala at nagbebenta ng mga produktong hindi rehistrado o aprubado ng FDA, maging mga pekeng gamot. Mayroon nang ginawa ang FDA na coordination activities o pagsangguni sa mga Law Enforcement Agencies tulad ng National Bureau of Investigation at PNP-CIDG para makompiska ang mga peke o hindi rehistradong mga gamot sa iba’t ibang rehiyon sa Pilipinas.”

Overall, Domingo stressed in the search for pharmaceutical intervention against COVID-19, he maintained that there must be a balance in speeding up the trial and ensuring safety, explaining that trials are important as it maintains welfare of those participating in the trials.

“Naiintindihan natin na lahat tayo ay sabik na makapahanap ng lunas para sa COVID-19, pero gusto rin nating maging maingat at mapanuri sa mga gamot na gagamitin natin. Hindi biro at basta-basta lang ang pagbibigay ng gamot dahil may mga epekto ito na maaaring hindi maging kaaya-aya. Kinakailangang suportado ng scientific evidence at ethical basis ang mga desisyon,” Domingo concluded.