The University of Kansas Medical Center will take part in a nationwide clinical trial of different treatments for patients suffering mild to moderate symptoms of COVID-19 who do not require hospitalization.
The first treatment will involve the use of monoclonal antibodies that target the spike proteins of COVID-19. The drug was made by Eli Lilly.
Monoclonal antibodies are engineered versions of the same virus-fighting antibodies that the body naturally produces.
The clinical trial, dubbed ACTIV-2, is one of at least 40 around the country aiming to recruit participants within 10 days of the onset of symptoms or within seven days of a positive test.
“This is a very important trial to help us find outpatient treatments for COVID-positive patients to hopefully prevent further hospitalizations, long-term complications and deaths from devastating disease,” said Dr. Leslie Spikes, an assistant professor of pulmonary and critical care medicine at KU Med and a co-investigator for the trial.
Lead investigator Dr. Mario Castro, a pulmonologist and vice chair for clinical and translational research at KU Med, said the trial will allow for the introduction of multiple agents to combat COVID-19 as they become available.
“New potential treatments can be added under the same trial protocol,” Castro said.
Last week, Eli Lilly reported interim results from a placebo-controlled trial of its monoclonal antibody drug, which was cloned from the antibodies of a patient who recovered from COVID-19.
Five of 302 patients who received the drug ended up being hospitalized, according to an Eli Lilly press release. By contrast, nine of the 150 patients who received a placebo were hospitalized. That means the patients who received the drug had a 72% reduced risk of hospitalization.
But as reported in STAT, a health news website, only the middle dose, 2,800 milligrams, met the trial’s primary goal of significantly reducing patients’ levels of the virus after 11 days. The failure of the higher dose to accomplish the same result could mean that the effect of the middle dose was merely due to chance, STAT reported.
People with active COVID-19 symptoms who are interested in participating in the study can contact Luigi Boccardi at 913-588-4022. KU Med is also partnering with The University of Kansas Health System to recruit participants through its outpatient clinics and swab clinics.
KU Med, along with Children’s Mercy Hospital, is also conducting a clinical trial of a COVID-19 vaccine developed by the University of Oxford and drug maker AstraZeneca. Castro is an investigator for that trial as well.
The AstraZeneca vaccine trial was suspended earlier this month after a participant in the United Kingdom developed an adverse reaction. Trials have since resumed in the United Kingdom but not in the United States.
