While the clinical trial of Avigan has finally started, the Department of Health (DOH) said it is working to revise its recruitment protocol as hospitals are having difficulty enrolling participants in the much-delayed trial of the Japanese antiflu drug.
Of the 100 patients needed for the trial to test Avigan’s effectiveness in treating COVID-19 infections, only four have been recruited as of Thursday, Health Undersecretary Maria Rosario Vergeire said.
Criteria for selection
Two of the patients are at the Philippine General Hospital, while the other two are each admitted at Jose N. Rodriguez Memorial Medical Center and Quirino Memorial Medical Center.
For applicants between 18 and 74 years old who wish to qualify for the trial, he or she should have only mild symptoms, must not require oxygen therapy and should not have any concomitant bacterial infection.
But this and other exclusion criteria, Vergeire said, may be hindering the recruitment process—especially the criterion that only patients admitted in hospitals are eligible to participate in the tests.
“Right now there aren’t that many patients with mild symptoms being admitted in our hospitals … This poses a challenge to our Avigan clinical trial team,” Vergeire said.
She added “It was discussed that we restrategize and revise our protocol so we can expand the recruitment and reach the 100 [participants] so that we can have this analysis for Avigan.”
Further review
In the meantime, hospitals will continue looking for volunteers under the existing protocol, Vergeire said. This is because the revised guidelines will have to undergo another review by an ethics board organized by the DOH.
“While we are awaiting that revision in protocol, we are also looking at how we could further expand our strategies for recruiting,” she said.
The trial was initially scheduled to start in mid-July but was delayed as legal arrangements were finalized.
The Japanese government delivered in early August enough of the tablets for 100 patients.
Virus case update
Meanwhile, the DOH logged on Friday an additional 2,092 cases, pushing the national tally to 391,809.
Davao City recorded the most number of new infections, 129, followed by Quezon City (100), Quezon province (83), Northern Samar (82) and Cavite (80).
The total number of COVID-19 survivors rose to 349,974 with the recovery of 462 more patients. The death toll, however, climbed to 7,461 as 52 patients succumbed to the severe respiratory disease.
The recoveries and deaths left the country with 34,374 active cases, or 8.8 percent of the total, of which 83.6 percent are mild, 9.8 percent asymptomatic, 2.4 percent severe and 4.2 percent critical.