Keck Medicine of USC physicians are enrolling patients as part of an international clinical trial to evaluate the safety and efficacy of an antiviral drug, DAS181, as a possible treatment for hospitalized patients with severe COVID-19.
DAS181 has demonstrated to be effective in fighting respiratory viruses, and limited preliminary data has suggested the drug may be beneficial for COVID-19 patients.
"The medication is thought to stop SARS-CoV-2, the virus that causes COVID-19, from penetrating and attaching to the cells lining the respiratory tract, therefore reducing the impact of the virus," says Richard Castriotta, MD, a pulmonary critical care physician with Keck Medicine. "This drug may also improve patients' immune response to the virus. Both actions should help reduce the severity and duration of COVID-19."
Castriotta, who is also a professor of clinical medicine at Keck School of Medicine of USC, is leading the trial for Keck Medicine with fellow researchers Janice Liebler, MD, and Aniket Sharma, MD.
This Phase 3 clinical trial is a double-blind, randomized controlled study. Half the participants will receive DAS181 through a nebulizer that delivers a vaporized form of the medication to the lungs and half will receive a placebo. The nebulizer is fitted with a mesh device that minimizes the risk of virus spread to health care workers.
Patients will receive the treatment twice a day from between 10 to 14 days, depending on their response. "The sooner someone recovers, the sooner they can stop the course of treatment," says Castriotta. Participants will be tracked for approximately one month after treatment.
The study is open to individuals 18 years or older with a confirmed case of COVID-19 who have pneumonia and require supplemental oxygen. Those on ventilators are excluded from the study. However, participants who require a ventilator during the course of the treatment may remain in the trial.
Participants will be enrolled at Keck Hospital of USC, which is one of more than 30 sites across the United States and in Australia, South Korea and Taiwan participating in the trial.
DAS181 is manufactured by Ansun Biopharma, Inc., which is sponsoring the study.
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