Clinical trial of remdesivir to continue

MANILA, Philippines — The clinical trial of remdesivir as a potential COVID-19 treatment would continue as the Department of Health (DOH) said Monday that the World Health Organization (WHO) needed more data to back its initial findings that the antiviral drug did little or had not helped in reducing deaths among infected patients.

“WHO wants it to be continued. They would want more information, more data, and they would want more accurate findings for remdesivir to support the initial results,” Health Undersecretary Maria Rosario Vergeire said.

But unlike remdesivir, the trial arm for interferon was halted since it “failed to achieve its objective” of reducing mortality among COVID-19 patients, Vergeire said.

Earlier, WHO said that remdesivir, interferon, lopinavir/ritonavir and hydroxychloroquine had “little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.”

The Solidarity Therapeutics Trial enrolled a total of 11,266 patients in 405 hospitals in 30 countries. As of Oct. 12, the Philippines accounted for 1,146 patients, of which 588 are in public hospitals.

Of these patients, 388 were given remdesivir, while 168 received interferon. A total 439 patients did not receive any of the trial medicines and were on supportive care.

“No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalization duration,” read the preprint WHO study.

Despite the findings, the United States’ Food and Drug Administration (FDA) approved the use of remdesivir on adult and pediatric patients aged 12 above for the treatment of COVID-19 requiring hospitalization.

WHO chief scientist Dr. Soumya Swaminathan said over the weekend that it appears that when Gilead Sciences submitted to FDA its data on remdesivir for its approval, it “did not include the Solidarity Trial results.” This even as the American biopharmaceutical firm was given the findings of the study as early as Sept. 23.

“It appears that the Solidarity results were not considered [and] were not provided to FDA,” Swaminathan said.

“We believe that our results are very robust. And we hope that people who are doing treatment guidelines in other countries as well as regulators around the world will take note of our study results in addition to the other evidence. Because you need to look at the global evidence for a drug before you make decisions,” she added.

Though the interferon arm of the trial has been suspended, Vergeire said two other treatments are soon expected to begin. One would use the chemotherapeutic drug acalabrutinib, and the other would test the effectiveness of monoclonal antibodies.

Meanwhile, Vergeire said that the Solidarity Trial for Vaccines is now scheduled to start in December. Science Secretary Fortunato dela Peña added that the trials will be piloted in the Americas in November, to be followed by other clinical trial sites, including the Philippines.

WHO is expected to come out with the list of vaccines included in the trials Monday.