PH’s Avigan clinical trial misses Sept. 1 target start date

Kristine Sabillo, ABS-CBN News

Posted at Sep 02 2020 12:46 PM | Updated as of Sep 02 2020 12:48 PM

MANILA — The country’s clinical trials for the drug Avigan, which has shown promising effects on COVID-19 patients, have yet to start due to processing delays.

Health Undersecretary Maria Rosario Vergeire said participating hospitals missed the target start date. The Department of Health earlier said the trials would begin on September 1 after initial delays.

“Hindi po ito naumpisahan kahapon kasi nagkakaroon tayo ng delays dito sa ethics reviews among the different hospitals identified na kasama dito,” Vergeire said during a virtual briefing.

(They weren't able to start yesterday because we had delays in ethics reviews among the different hospitals identified that are part of this.)

She said the ethics boards of the Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital, and Quirino Memorial Medical Center have yet to finish their respective reviews.

“'Yung sa PGH (Philippine General Hospital) 'yung MOA (memorandum of agreement) is currently for legal review na ng UP (University of the Philippines) Manila. Pero mayroon na silang approved ethics na review,” the health official added.

(For PGH, the MOA is already under legal review of UP Manila. But they already have an approved ethics review.)

Vaccines and drugs that have yet to receive regulatory approval need to go through ethics review by individual hospitals and national ethics boards to ensure the safety of patients.

Avigan or favipiravir is originally an anti-flu drug but clinical trials in some countries showed promising results.

Vergeire said the clinical trial agreement is also waiting for the signature of Secretary Francisco Duque III after their legal offices gave their inputs.

“Once all of these have been processed and approved we will already start,” she said.

The four hospitals will be running the clinical trials on a total of 100 patients. The DOH earlier said it would run for 9 months.

Enough dosage has already been given by the Japanese government although Vergeire said on Wednesday that they received another donation of favipiravir through the National Security Council.

“Aside from this trial that we are going to have, mayroon pong nag-donate sa atin ng I think 199,000 tablets of this Avigan medicine,” Vergeire said, adding that the donation was distributed to different hospitals.

(Aside from this trial that we are going to have someone donated I think 199,000 tablets of Avigan.)

While the tablets will not be used for clinical trials, hospitals can apply for a compassionate special permit with the Food and Drug Administration to allow its use for COVID-19 patients.

Manila Mayor Isko Moreno last week posted on social media that they received 976 tablets of the drug for one of the city's local hospitals.

The Philippines now has the most number of COVID-19 cases in Southeast Asia with over 224,000 infections, despite having one of the longest lockdowns in the world.