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Avigan trial still awaiting finalization of legal documents — DOH

The clinical trials for anti-flu drug Avigan as a treatment for COVID-19 has yet to start in the Philippines because some legal documents are still being ironed out, Health Undersecretary Maria Rosario Vergeire said Friday.

"We are just waiting for the finalization of the documents, 'yung clinical trial agreement at saka 'yung iba pang mga documents," Vergeire said in an online forum of the Department of Health.

"'Yung clinical trial agreement we are still waiting that these be signed by the chancellor of UP Manila so hanggang ngayon nasa kanila pa rin... Ito na lang clinical trial agreement ang ating hinihintay, so hopefully by next week we can have this already," she added.

The Philippine government initially targeted to start this trial in August but it was further moved to September.

The scheduled commencement of the trial on September 1 did not push through because three hospitals participating in the clinical trials have yet to finish their ethics review on Avigan.

Nonetheless, Vergeire said it still targets to start the trial this month.

Food and Drug Administration director general Eric Doomingo said the Avigan study was approved as early as July.

Preliminary results may be generated "midway" into the trial after it starts, he said.

He added that the progress of Avigan clinical trials in Japan may also fast-track the registration process of the drug in the Philippines.

"If the clinical trials in Japan are already conclusive, then they can also use that for registration purposes here in the Philippines which will make it easier and faster to register the product," Domingo said.

The Avigan clinical trial in the Philippines will involve 100 patients in selected hospitals in NCR including the Philippine General Hospital, Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital and Quirino Memorial Medical Center.

It would run for a period of nine months, according to the DOH. — RSJ, GMA News