Ethics board approves PH participation in WHO clinical trials for COVID-19 cure

Kristine Sabillo, ABS-CBN News

Posted at Apr 22 2020 11:15 PM | Updated as of Apr 22 2020 11:55 PM

It was during the first week of April that the DOH said it was joining the WHO global clinical trials, alongside more than 100 countries. Denis Balibouse, Reuters/file

MANILA — More than 2 weeks since the government said the Philippines will be participating in a multi-country clinical trial for COVID-19 treatment, the Department of Health announced it has gotten a green light from a national ethics board. 

The DOH on Wednesday said the Philippines’ participation in the World Health Organization’s Solidarity Trial was approved by the Single Joint Research Ethics Board (SJREB) last April 17.

The SJREB is a Philippine Health Research Ethics Board-accredited research ethics committee.

“Dahil ang gamot ay hindi pa proven, bukod sa may risk or harm, may risk din na walang epekto. Dahil dito, ang doktor ay may ginagawa pang extra step of informed consent,” Health Undersecretary Maria Rosario Vergeire said during a televised briefing.

(Because the drug is still not proven effective, besides having possible risks or harm, there is also a risk that it will have no effect. Because of this, the doctor will have to undertake an extra step to get the patient’s informed consent.)

“The ethics review process ensures that all these 20 hospitals na kasama sa trial ay gagawin ito para walang pasyenteng magsasabi o makakaramdam na sila ay nalinlang kung hindi sila gagaling sa mga gamot na ibibigay sa kanila,” she added.

(The ethics review process ensures that all these 20 hospitals participating in the trial will do this so that no patient will feel that they were misled if their condition does not improve from the drugs given to them.) 

It was during the first week of April that the DOH said it was joining the global clinical trials, alongside more than 100 countries.

The clinical trials, which will involve the participation of local hospitals, are looking into the effectivity of off-label drugs (1) remdesivir, (2) lopinavir and ritonavir combined, (3) lopinavir and ritonavir plus interferon beta, and (4) chloroquine.

“Dito pinagtatapat-tapat ang iba ibang gamot at random ang pag-assign ng pasyente kung sino ang makakakuha o hindi makakakuha ng gamot na ito,” Vergeire said in a televised briefing on Wednesday.

(This is where different drugs are compared and are randomly assigned to patients.)

The DOH earlier said that patients who opt into the clinical trials will be randomly assigned to each of the off-label drugs included in the study.

These off-label drugs were originally made to treat other diseases such as malaria or Ebola. It takes several months or years to develop a drug to treat a disease such as COVID-19, so experts have resorted to finding existing drugs that could help treat the new strain of coronavirus.

“There is currently no magic drug or known treatment for COVID-19 and there is an urgency to find effective treatment,” Vergeire said. 

“We are optimistic that this megatrial, with over 90 participating countries, will promote the rapid generation of strong evidence for treating COVID-19, and ultimately stem this pandemic.”

In a statement, WHO acting representatives Dr. Socorro Escalante said more countries participating in the trial would help expedite its results.

Worldwide, there have been 2.5 million people infected with COVID-19 since the start of the pandemic, according to the Johns Hopkins University coronavirus dashboard. Of this number, 6,710 COVID-19 patients have been recorded in the Philippines. 

The DOH has repeatedly said that there is still no known cure or vaccine for COVID-19. There are, however, several clinical trials being done or planned in the Philippines. These include plasma transfusion and virgin coconut oil treatment. 

Holding clinical trials or experimental treatments in the Philippines requires approval from the Food and Drug Administration.

Vergeire said the FDA has not given approval to any placenta-based treatment, such as the one being done in Israel.

She also said that another off-label drug that may be for the treatment of COVID-19 patients in the Philippines is immunosuppressive drug tocilizumab, which is included in the clinical management guidelines of the Philippine Society of Microbiology and Infectious Diseases.

“Maaari rin pong pag-aralan ang Avigan (favipiravir) mula sa Japan,” she added.

(We can also study Avigan from Japan.)

Avigan is considered a promising drug after clinical trials in Japan showed encouraging results when it was used to treat COVID-19 patients.