A new clinical trial offered by Advocate Aurora Research Institute will evaluate whether an investigational drug can prevent viral lung infections, such as COVID-19, from progressing to severe lung injury and acute respiratory distress syndrome (ARDS).
ARDS is a potentially deadly lung condition in which inflammation makes it harder to breathe, leading to low oxygen levels and organ failure.
“Most viral infections do not cause severe lung injury and ARDS, but in some cases patients require mechanical ventilation – a breathing machine – to support them while they recover from the infection. In rare cases, patients may require lung bypass, also known as extracorporeal membrane oxygenation or ECMO,” said Valerie Griffeth, MD, PhD, a critical care physician and study principal investigator for Advocate Lutheran General Hospital in Park Ridge, Illinois. “The goal of this study is to determine whether tozorakimab can prevent viral infections from progressing to lung failure.”
The Research Institute has opened the study at Advocate Lutheran General and Aurora BayCare Medical Center in Green Bay, Wisconsin.
Researchers will give clinical trial participants the study drug in addition to the standard of care for patients who already require supplemental oxygen.
“With a run of deadly new respiratory viruses in the past couple decades – including H1N1, MERS and, of course, COVID-19 – doctors have reported significantly higher rates of ARDS, which has created the need for new effective treatments,” said Raul Mendoza-Ayala, MD, pulmonologist and Aurora BayCare’s principal investigator for the study.
Prior research has shown that early intervention is important when treating ARDS. Much of that research, however, was limited only to treating people with COVID-19 and not other types of viral infections, which is why additional studies are needed.
“Advocate Aurora Research Institute is proud to support clinical trials such as this one that could help prepare us for the next viral pandemic as well as inform treatment of infectious diseases long known to be endemic locally,” said Laura Wrona, MSN, director of the Research Institute’s specialty clinical trials.
The clinical trial is randomized, double-blinded and placebo-controlled, meaning participants will be randomly assigned to receive either tozorakimab or a placebo, and neither they nor their doctor will know which they received until after the study has completed.
Researchers across the country plan to enroll more than 2,300 total participants in the clinical trial, “Efficacy and safety of tozorakimab in patients hospitalised for viral lung infection requiring supplemental oxygen (TILIA),” which is sponsored by AstraZeneca, manufacturer of tozorakimab.
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