According to the pivotal data from the randomized, center, open-label COMET-TAIL Phase 3 study. Administration of the drug was effective for up to 7 days after the onset of symptoms, according to the study.
“I am happy that [the] results showed similar efficacy for sotrovimab when injected directly into muscle compared to intravenous administration, potentially providing an easier option for patients,” said Hal Barron, MD, chief scientific director and president of GlaxoSmithKline, in a press release. “We look forward to working with regulatory authorities to make this new option available to eligible patients with COVID-19.”
The study enrolled 983 patients, initially divided into 3 arms: 500 mg sotrovimab administered intravenously, 500 mg administered intramuscularly and a low dose of 250 mg administered intramuscularly. The low-dose intramuscular cohort was discontinued after a higher number of hospitalizations in that cohort. In the 500 mg intramuscular arm, the rate of progression to hospitalization over 24 hours or death was 2.7% compared to 1.3% in the IV arm. The adjusted difference in progression rate between arms was 1.07% with a 95% confidence interval of -1.25% to 3.39%.
“This trial was conducted during the peak of the circulation of the Delta variant, with significant enrollment in Florida – a hot spot for this particular variant and where the hospitalization rate averaged more than 10% of confirmed cases,” said George Scangos, PhD, chief executive officer of Vir Biotechnology, in the release. “We designed sotrovimab to be resistant to the variants we expected to occur, and these data show that sotrovimab administered via IV or IM may prove important in the fight against COVID-19 after authorization. As we approach the third year of the pandemic, we can expect that multiple treatment options will continue to be needed, especially for at-risk patients with complex health needs.”