U.S. drugmaker starts phase 3 trial for COVID-19 antibody treatment

Yolanda Curtis
August 5, 2020

The National Institute of Health (NIH), along with its National Institute of Allergy and Infectious Diseases arm, will conduct a Phase 2 clinical trial of Eli Lilly's (LLY) LY-CoV555 monoclonal antibody. The trial is meant to be adaptive to emerging information, so patients can be enrolled mid-study and the protocol can be used to evaluate the safety and efficacy of several different monoclonal antibody treatments.

Lilly's LY-CoV555, which is being developed in partnership with Canadian biotech AbCellera, is already being studied as a COVID-19 treatment in patients who have contracted the disease.

Colorized scanning electron micrograph of a cell (purple) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample.

The National Institutes of Health (NIH) announced today it is moving forward with 2 clinical trials to evaluate therapeutics against coronavirus 2019 (COVID-19), including 2 monoclonal antibody-based treatments, as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. If there are no serious safety concerns and if the investigational therapeutic appears to meet other specific other criteria (such as sufficiently reducing the duration of symptoms or the viral load in the volunteers' bodies), the trial will transition to Phase 3 and enroll up to 1,780 additional outpatient volunteers, for a total of 2,000 trial participants. "Prioritized therapeutics under ACTIV will use a master protocol that emphasizes flexibility, which enables these critical trials to be conducted without incurring delays when a treatment shows promise".

In contrast to the convalescent plasma taken from survivors' blood, monoclonal antibodies can be manufactured in large amounts in a lab. Fifty-six participants had antibodies and no side effects in one study, and the other showed the vaccine protected monkeys from COVID-19.

The second trial, ACTIV-3, will include sicker patients: those who are hospitalized with COVID-19, but do not have end-stage organ failure.

If an investigational therapy is unsafe or not likely to be effective, it will be dropped, the NIH said in a statement. Initially, 220 volunteers will be enrolled and assigned to receive either an intravenous infusion of Ly-CoV555 or placebo infusion. Participants also will receive standard care for COVID-19, including the antiviral remdesivir. The trial will be led by the NIAID-funded AIDS Clinical Trials Group (ACTG) and will enroll participants at sites around the world. The goal of the ACTIV-3 trial is to determine whether patients continue to recover for 14 days at home after they are released from the hospital.

The principal investigator of ACTIV-3 is Jens Lundgren, M.D., of the University of Copenhagen and Rigshospitalet.

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