LOS ANGELES (CNS) - Keck Medicine of USC announced today it is enrolling outpatient volunteers in a national phase 3 clinical trial to test the efficacy and safety of the monoclonal antibody drug LY-CoV555 for mild to moderate COVID-19.
Monoclonal antibodies are synthetic versions of the antibodies the body naturally produces when exposed to SARS-CoV-2, the virus that causes COVID- 19. When given during the early stages of COVID-19, these antibodies may prevent the virus from replicating and spreading.
"The monoclonal antibody LY-CoV555 has shown some efficacy in early studies in preventing patients with mild to moderate COVID-19 from being hospitalized," said Dr. Saahir Khan, co-principal investigator of the trial site and an infectious disease specialist with Keck Medicine. He is also a clinical assistant professor of medicine at the Keck School of Medicine of USC.
"So far, it is the only treatment to do so."
Monoclonal antibodies made headlines in early October when President Donald Trump was treated for COVID-19 with an experimental monoclonal antibody drug made by Regeneron.
Dr. Michael Dube, an infectious disease specialist with Keck Medicine and interim chief of the Division of Infectious Diseases with the Keck School, is the co-principal investigator of the study.
Those participating in the randomized, double-blind trial will be enrolled at the Keck Medicine COVID-19 medical evaluation tent and receive a one-time infusion of either the drug or a placebo at the tent.
Participants will keep a symptom diary for the first 28 days after the infusion, and their progress will be tracked for 24 weeks either through in-person or virtual visits.
To qualify for the study, participants must:
-- be 18 or older;
-- be showing symptoms of COVID-19 but not have been hospitalized for the disease; and
-- have tested positive for SARS-CoV-2 infection within seven days of enrollment and started experiencing symptoms within 10 days of enrollment.
The study aims for half of participants to have risk factors for developing a severe case of COVID-19, including those 55 or over or who have a preexisting condition such as diabetes, asthma or hypertension.
Keck Medicine will enroll patients who have tested positive for COVID- 19 at all Keck Medicine hospitals and ambulatory locations, including Keck Hospital of USC, USC Norris Cancer Hospital and USC Verdugo Hills Hospital, as well as County-USC Medical Center and neighboring outpatient clinics.
Those interested in participating in the study can learn more or volunteer at riseabovecovid.org/en.
This trial is part of a larger study, "ACTIV-2: A Study for Outpatients With COVID-19," examining the safety and effectiveness of different drugs in treating COVID-19 in outpatients.
ACTIV, which stands for Accelerating COVID-19 Therapeutic Interventions and Vaccines, brings private organizations and public agencies together to coordinate research strategies and speed the development of the most promising treatments and vaccines for the coronavirus.
The study is sponsored by the National Institute of Allergy and Infectious Diseases and the AIDS Clinical Trials Group. The monoclonal antibody drug LY-CoV555 is manufactured by Eli Lily.
Memorial Care Long Beach Medical Center announced in May that it is participating in two multi-national clinical trials testing the effectiveness and safety of two different anti-viral treatments designed to reduce the severity and potentially stop the spread of COVID-19 in both hospitalized and ambulatory patients.
Memorial Care's research team, led by pulmonary and critical care medicine specialist Dr. Jimmy Johannes, is studying a combination of two monoclonal antibodies developed by Regeneron.
The antibodies are designed to target and block the "spike" protein of SARS-CoV2, which is the part of the virus that attaches to and infects healthy human cells. The use of monoclonal antibodies as an anti-viral has been shown to be effective in treating Ebola.
"One of the most important ways our immune system fights infections from viruses is by making antibodies against the virus. Because of this, the use of monoclonal antibodies against SARS-CoV2 is considered to be a very promising approach for treating COVID-19," Johannes said.