PH Avigan clinical trial falls short of scheduled start date of September 1

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

The Undersecretary of Health, María Rosario Vergeire, said that the participating hospitals did not meet the scheduled start date. The Health Department previously said that the trials would begin Sept. 1 after initial delays.

“It did not start yesterday because we are having delays here in the ethics reviews between the different identified hospitals that are included here,” Vergeire said during a virtual briefing.

(They couldn’t start yesterday because we had delays in ethics reviews between the different identified hospitals that are part of this.)

She said the ethics boards of Sta. Ana Hospital, Dr. José N. Rodríguez Memorial Hospital, and Quirino Memorial Medical Center have not yet completed their respective reviews.

“The PGH (Philippine General Hospital) MOA (memorandum of agreement) is currently up for legal review by UP (University of the Philippines) Manila. But they already have an approved ethical review ”, added the health official.

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

Vaccines and drugs that have not yet received regulatory approval must undergo ethical review by individual hospitals and national ethics boards to ensure patient safety.

Avigan or favipiravir is originally a flu medicine, but clinical trials in some countries showed promising results.

Vergeire said the clinical trial agreement is also awaiting the signature of Secretary Francisco Duque III after his law offices provide input.

“Once all of these have been processed and approved, we’ll get started,” he said.

The four hospitals will carry out clinical trials with a total of 100 patients. DOH previously said it would run for 9 months.

The Japanese government has already administered a sufficient dose, although Vergeire said Wednesday that they received another donation of favipiravir through the National Security Council.

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

(Apart from this test that we are going to donate to someone, I think 199,000 Avigan tablets).

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

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

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