Trial will assess antibody treatment among patients hospitalized with COVID-19
A global clinical trial will test the safety and efficacy of monoclonal antibody treatments among patients hospitalized with COVID-19, the NIH announced.
According to an NIH press release, patients admitted to the hospital with COVID-19 can begin volunteering to take part in the phase 3 randomized, controlled trial known as ACTIV-3, which will begin by testing the investigational monoclonal antibody known as LY-CoV555, which was discovered in a blood sample of a patient who recovered from COVID-19.
The trial is designed to expand to test multiple different kinds of monoclonal antibody treatments.
“Under Operation Warp Speed, the U.S. government has brought together multiple agencies to accelerate the development, manufacture and distribution of medical countermeasures for COVID-19,” NIH Director Francis S. Collins, MD, PhD, said in the release. “The ACTIV studies are just a few examples of this critical activity, which emphasizes flexibility and minimizes delays to generate scientifically sound results.”
According to the NIH, the first stage of ACTIV-3 will enroll around 300 volunteers who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms. Once COVID-19 infections have been confirmed and patients have consented to take part in the study, they will be randomly assigned to receive either an intravenous infusion of LY-CoV555 or a saline placebo infusion, as well as standard care for COVID-19, including remdesivir. According to the release, after 5 days, researchers will assess participants’ symptoms, need for supplemental oxygen, mechanical ventilation or any other supportive care. All participants will be followed for 90 days and will have blood samples taken periodically to analyze their response.
“Studying the impact of this investigational therapeutic on multiple patient populations at the same time is critical to determining whether it can help COVID-19 patients with differing levels of disease severity,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said in the release. “These concurrent trials have the potential to yield significant and comprehensive clinical data.”