DOH: PH clinical trials for Avigan yet to start but requirements nearing completion

Kristine Sabillo, ABS-CBN News

Posted at Sep 11 2020 01:40 PM | Updated as of Sep 23 2020 01:03 PM

Anti-influenza Avigan Tablets produced by Japan's Fujifilm are displayed in Tokyo on Oct. 22, 2014. Kazuhiro Nogi, AFP/FILE

MANILA — More than a month after the Philippines received anti-flu drug Avigan from the Japanese government, the country has yet to start its clinical trials.

But the Department of Health on Friday said the requirements for the clinical trials, which seek to test how effective Avigan is against COVID-19, are almost complete.

The DOH earlier said that the Avigan clinical trial would start in August but that was moved to September 1. However, that did still not push through because of pending requirements, specifically the ethics review board approvals of the participating hospitals.

“The case report form database was already tried out last Monday. Nagkaroon ng dry run kung saan meron ulit ngayong araw na ito base sa mga komento na na-receive during Monday’s dry run,” Vergeire told reporters on Friday.

(The case report form database was already tried out last Monday. There was a dry run and it will again be done Friday, based on the comments received during Monday’s dry run.)

The database is among the requirements needed to asses the results of the clinical trial.

“Yung tablets na gagamitin para sa database na ito naibigay na ng DOH doon sa trial group ng Avigan at hinahanda na lang natin yung deed of donation,” Vergeire added.

(The tablets that will be used for the database were already given by the DOH to the Avigan trial group and we are just preparing the deed of donation.)

Vergeire said that once the database and agreements are finalized they can already start.

She said the DOH legal office already gave comments on the clinical trial agreement and the team handling the trial is already responding to it, “so we can expedite the clinical trial agreement.”

“As to insurance coverage meron na tayong nare-ceive na quote from the insurance coverage and ito ay inaayos na lang natin with the proper documentation,” she said.

(As to insurance coverage, we have received a quote for insurance coverage and we are preparing this with proper documentation.)

She said a monitoring committee will also be set up based on a meeting with the Philippine Council for Health Research and Development last Wednesday.

It was back in March that the Philippines asked Japan for allocation of Avigan following “promising” results of clinical studies in Japan. It has also been used in China to treat COVID-19.