Scientists from the National Institutes of Health (NIH) and Eli Lilly have announced the launch of two human trials that will assess the safety and efficacy of an experimental monoclonal antibody called LY-CoV555 for the treatment of COVID-19, the infection caused by the novel coronavirus.
NIH Head Dr. Francis Collins said, “This is a significant day, but it’s also an example of how the best clinical science can only happen with public participation.”
He added, “We will be earnestly seeking individuals who’ve been found to be infected with SARS-CoV-2 virus and who are interested in taking part in seeking answers to a critical question: can monoclonal antibodies reduce severity of COVID-19? Can that approach even save lives?”
The announcement marks the latest development in an attempt from the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, which was launched in April to bolster the development of the most promising drugs, treatments and vaccine candidates.
Researchers at AbCellera Biologics and the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID) discovered the antibody LY-CoV555 in a blood sample of a recovered COVID-19 patient in the state of Washington.
Later, Eli Lilly teamed up with AbCellera to develop and manufacture the antibody.
In one trial, the researchers plan to study the safety and efficacy of the antibody in 200 patients with mild to moderate COVID-19 symptoms who are not hospitalized. Half of the participants will receive the antibody and the other half a placebo.
NIAID Head Dr. Anthony Fauci said that the primary objective of this trial is “to determine whether the investigational treatment reduces the duration of symptoms through 28 days and increases the proportion of the volunteers who have undetectable virus in the nasopharynx at various periods of time ranging from 3 days to 28 days.”
“If transitioned to phase 3, [this trial will] determine if in fact the intervention reduces the risk of hospitalization and/or death,” he added.
In another trial, the scientists will examine the safety and efficacy of LY-CoV555 in 300 hospitalized patients with COVID-19 symptoms. Half of them will receive the antibody and the other half will be given a placebo.
Dr. Fauci explained that if the treatment appears to be effective, “this [the second trial] will go on to a second phase of 700 individuals, for a total of 1000 [patients].”
“The entry criteria for this trial are symptoms [of COVID-19] for 12 days or less, requiring hospitalization but without end-stage organ failure,” he added. “The primary objective is a sustained recovery for 14 days at home after hospital discharge.”
Dr. Fauci said these two clinical trials are important from the overall standpoint of helping doctors to manage patients with COVID-19.
“We have good therapies for late disease: dexamethasone for people on ventilators or requiring oxygen, and remdesivir for hospitalized patients with documented lung disease,” he said.
“This is important because we’re talking about people who don’t require hospitalization in ACTIV-2, and those who are in the hospital but don’t require the kinds of interventions that we see in late-stage disease, in ACTIV-3.”
Chief Scientific Officer of Eli Lilly Dr. Dan Skovronsky described the launch of these two trials as an “Apollo 11 moment” in the battle against the ongoing pandemic. He said, “Today we have liftoff. We can’t be sure we’ll reach our destination on this mission, but our biopharmaceutical industry and our public health partners won’t give up until we do.”
