Gilead Sciences, Inc announced that it conducted phase 3 trials for the antiviral drug remdesivir in patients with moderate COVID-19 pneumonia who were admitted to hospitals.
The effects of the drug were studied through 5-day as well as 10-day courses of it with standard care as opposed to just the regular hospital care. As a result of this study, it was observed that 65% of patients, who received a 5-day course of the drug, showed improvement in their condition by the 11th day as compared to those receiving regular hospital care. Further, the patients receiving 10-day course of the drug showed favourable but not highly significant improvements as compared to the patients receiving standard care.
As of now, this drug has only been approved by Japan for the treatment of patients suffering from the respiratory disorder, COVID-19. Remdesivir has further been granted an Emergency Use Authorization by the United States Food and Drug Administration (FDA). This will allow the drug to be used in the form of an investigational and unapproved drug for the treatment of patients with severe cases of COVID-19 who are in hospitals.
Initially, the study consisted of around 600 randomized patients, equally distributed into all three categories. After an expansion phase later, an additional 1,000 patients with moderate disease were added to the study. The above stated results were of the initial phase of the study with 600 people. As remdesivir is currently an investigational drug, it is not known whether the drug is safe or effective for the treatment of this disease. The drug, however, was found to be well-tolerated in patients belonging to the both 5-day and 10-day course groups with a few side effects such as headache and nausea occurring in more than 5% of patients.
Gilead conducted these phase 3 trials for remdesivir at more than 180 centers all over the world, in countries including United States, Germany, China, Japan, France, Italy, Singapore, Spain, Switzerland, United Kingdom, Hong Kong, Korea, Sweden, the Netherlands and Taiwan.
