As the quest for COVID-19 treatments continues, the National Institutes of Health (NIH) is starting an adaptive trial to test experimental antibody treatments for the disease. It’s starting with Eli Lilly and AbCellera’s candidate but could add more prospects as the trial goes on.
Dubbed ACTIV-3, the two-stage trial will enroll about 300 patients who have been hospitalized with mild or moderate COVID-19, and who have had symptoms for fewer than 13 days, the agency said in a statement on Tuesday. Those patients will receive Lilly’s antibody, LY-CoV555 or placebo via intravenous infusion.
After five days, investigators will assess the patients’ symptoms and whether they needed supportive care, like supplemental oxygen or mechanical ventilation. At this point, they’ll decide whether or not to test the drug in more patients. If Lilly’s treatment gets the green light, the study will enroll another 700 patients, including sicker ones who may need supportive care for organ failure. If it’s deemed unsafe or not likely to be effective, it will be dropped.
The patients will be followed for three months, undergoing examinations and giving blood samples so the investigators may analyze their response to the drug.
The trial design allows additional antibodies to be tested in the first or second stage of the study, and for more patients to be recruited in the middle of the trial, the NIH said. Patients at “select hospitals” may volunteer to participate in the study; these include sites that are already part of clinical trial networks aroind the world, such as the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), the Prevention and Early Treatment of Acute Lung Injury network (PETAL) and Cardiothoracic Surgical Trials Network (CTSN), all of which are operated or supported by NIH bodies.
“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,” said NIAID Director Anthony Fauci, M.D., in the statement. “These concurrent trials have the potential to yield significant and comprehensive clinical data.”
Lilly’s antibody is already in multiple studies, including an NIAID-run phase 2 study in patients with mild to moderate COVID-19 who have not been hospitalized. Lilly is also running its own phase 1 study in hospitalized patients, as well as a phase 3 study in nursing homes. It is testing a second antibody treatment with partner Junshi with plans to combine the two in a cocktail that could work better than either drug alone.