In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.
David Morrison | Eli Lilly via AP
The National Institutes of Health announced Tuesday it is starting two trials testing whether an experimental antibody drug can work as a safe and effective treatment in patients with Covid-19.
The trials, called ACTIV-2 and ACTIV-3, will look at U.S. drugmaker Eli Lilly’s experimental treatment known as LY-CoV555, which is being developed in partnership with Canadian biotech AbCellera. The companies announced Monday they began a phase three trial testing whether the treatment can prevent the spread of coronavirus in residents and staff at nursing homes.
One of the trials will test Eli Lilly’s experimental treatment on people with mild to moderate Covid-19 symptoms who have not been hospitalized.
The second trial, in a late stage, will look patients who have been hospitalized with mild to moderate Covid-19 with fewer than 13 days of symptoms and aims to enroll a total of 1,000 people. Once selected for the trial, participants will be randomly assigned to receive either an intravenous infusion of the drug or a saline placebo infusion.
Participants will also receive standard care, including doses of Gilead Sciences antiviral drug remdesivir. Participants will be assessed after five days and followed for 90 days after enrolling in the trial.
Researchers in the phase three trial want to see whether the antibody treatment can promote a sustained recovery for two weeks at home, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on a conference call with reporters.
“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,” Fauci said. “These concurrent trials have the potential to yield significant and comprehensive clinical data.”
The trials are part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines program, a partnership with drugmakers and other U.S. agencies to coordinate drug and vaccine research.
There are no FDA-approved drugs for the coronavirus, which has infected more than 18 million people worldwide and killed at least 694,715 in about seven months, according to data compiled by Johns Hopkins University. In May, the Food and Drug Administration granted remdesivir an emergency use authorization, allowing hospitals and doctors to use the drug on patients hospitalized with the disease even though the drug has not been formally approved by the agency.
Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells and scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.
The NIH trial can be modified to test additional experimental therapeutics, allowing novel treatments to enter, the NIH said.
Patients may now volunteer for the trial, which will take place at select hospitals around the world, the agency said.
The late-stage trial will initially enroll 300 participants. Researchers will add an additional 700 participants if Eli Lilly’s treatment proves to be safe and appears to be effective. Researchers also expect to enroll more severely ill participants, such as those with organ failure requiring mechanical support.
U.S. officials expect to have more than 100,000 doses of the treatment by the end of the year.
Researchers expect results from the trials by November, Fauci said.