Taipei, April 21 (CNA) The third-phase clinical trial of a drug to treat patients with COVID-19 has officially begun amid a surge in COVID-19 cases in Taiwan, Taiwanese pharmaceutical company PharmaEssentia Corp., the drug’s manufacturer, announced Wednesday.
Ropeginterferon alfa-2b (Ropeg), a novel long-acting pegylated interferon, was originally approved by the Taiwan Ministry of Health and Welfare as a treatment for patients with polycythemia vera (PV), according to PharmaEssentia.
After learning from recent studies that long-acting interferon therapy in general can effectively improve some clinical aspects of COVID-19, Shuang Ho Hospital began administering Ropeg in June 2021 to help treat patients with mild or moderate COVID-19 based on the compassionate use provision, according to the company.
It was found that 21 mild or moderate COVID-19 patients were discharged from the hospital within seven days after the use of the drug, it noted.
In August last year, after receiving approval from the health ministry, PharmaEssentia invited National Taiwan University Hospital to carry out a Phase 3 multi-center clinical trial of Ropeg for the treatment of COVID-19.
However, due to an improvement in the COVID-19 situation later last year, it was difficult to recruit patients for a clinical trial of the drug as a COVID-19 treatment so the trial was changed to an experimental study, according to the company.
A spike in new COVID-19 cases this year has prompted the resumption of patient recruitment for the clinical trial, PharmaEssentia said.
Based on the results of the use of Ropeg in Shuang Ho Hospital, a clinical trial involving the treatment of patients with moderate COVID-19 can be verified as long as 94 patients have been enrolled, the company indicated.
The company said that almost 10 patients with moderate COVID-19 had been recruited to participate in the trial so far, adding that Taoyuan General Hospital also joined the patient recruitment program on Wednesday.
The clinical data about the effect of Ropeg used in patients with COVID-19 has been published in the international peer-reviewed journal “Advances in Therapy,” according to PharmaEssentia.