The government has expanded the opportunity to test Gilead Sciences’ remdesivir, an investigational antiviral drug, against the infection of the new coronavirus (COVID-19).
The Ministry of Food and Drug Safety on Thursday approved an investigator-initiated phase-2 clinical trial of remdesivir on 100 hospitalized COVID-19 patients. The green light adds to the previous nods, made on Monday, for two phase-3 studies on 195 COVID-19 patients.
In total, 295 Korean patients will receive remdesivir to treat the deadly disease in clinical trials under the oversight of infectious disease specialists.
The two Gilead-led studies will take place at the Seoul Medical Center, the National Medical Center, and Kyungpook National University Hospital. The investigator-initiated study will be conducted at the Seoul National University Hospital (SNUH), Seoul Metropolitan Government-Seoul National University Boramae Medical Center, and SNU Bundang Hospital.
The local investigator-initiated trial is part of the randomized, controlled trial that the U.S. National Institutes of Health (NIH) announced on Feb. 25.
The NIH had said that the first participant of the study would be a U.S. citizen who was repatriated after being isolated aboard the Japanese cruise ship, Diamond Princess, which docked in Yokohama, Japan.
The NIH’s trial will be on 394 patients with COVID-19 around the world, including 100 Koreans who account for about 25 percent.
According to the government’s disclosure of the trial information, researchers will evaluate the primary endpoint on a seven-point ordinal scale -- death, hospitalization with invasive mechanical ventilation or extracorporeal membrane oxygen (ECMO), hospitalization with non-invasive ventilator or high flow oxygen concentrator, hospitalization requiring oxygen supplementation, hospitalization without oxygen supplementation, not hospitalized but restricted in activities, no hospitalization required, and no activity restrictions.
The secondary endpoints will include National Early Warning Score (NEWS) to determine whether patients were in a state of sudden emergency on day 15 and day 29, period of oxygen therapy, period of mechanical respiration therapy, hospitalization period, time of death time and cause of death, Grade 3 or higher side effects, serious adverse effects, and leukocytes, hemoglobin, platelets, creatinine, glucose, total bilirubin, liver function levels on day 3, 5, 8, 11, 15, and 29.
The participants of the trial will be randomly divided into the remdesivir group and the placebo group. They will receive intravenous administration of remdesivir or placebo once a day for 30 minutes for 10 days (or until discharged). The remdesivir group will get a 200mg dose of the drug on day one, followed by a 100mg dose from day 2.
The trial will start this month and end in March 2023.