UCI Health will initiate a clinical study of a drug to treat critically ill COVID-19 patients who face a high mortality rate because of acute inflammation that fills their lungs with fluid, a grave condition that even mechanical ventilation cannot improve.
Aviptadil, which has a 20-year history of use in human clinical trials for lung ailments, will be employed in a phase 2b/3 clinical study of COVID-19 patients suffering from acute respiratory distress syndrome, a primary cause of coronavirus-induced death, said Dr. Richard Lee, interim chief of UCI Health's Division of Pulmonary Diseases and Critical Care Medicine.
We're very pleased to be one of the first centers launching this clinical study. This study will focus on patients for whom mortality is alarmingly high. If successful, we hope that treatments such as Aviptadil may change the chances of survival for these patients."
Dr. Richard Lee, principal investigator for the Aviptadil clinical trial
Up to 30 patients at UCI Medical Center will be included in the trial. Eligible participants will be hospitalized patients who have ARDS due to COVID-19 and require intubation and mechanical ventilation.
The leading role of UCI Health in advancing this clinical research during the COVID-19 pandemic illustrates its unique and critical position in Orange County and beyond.
Part of the drug portfolio of Swiss company Relief Therapeutics Holding, Aviptadil has been used in trials for sarcoidosis, an inflammatory disease that attacks the lungs and lymph glands, as well as for pulmonary fibrosis and pulmonary hypertension.
A synthetic form of human vasoactive intestinal polypeptide, Aviptadil targets inflammatory molecules in the lungs called cytokines that COVID-19 whips into a storm, drenching the air sacs of the lungs in water and rendering them unable to deliver oxygen.
The drug could serve as one of the last lines of defense in cases where significant COVID-19 complications appear, often in the elderly and those suffering from other medical conditions, Lee said.
NeuroRx Inc., Relief Therapeutics' U.S. partner, with operations in Radnor, Pennsylvania, is leading the Aviptadil clinical trial. In a previous trial of vasoactive intestinal polypeptide for ARDS in eight patients with sepsis, seven people on mechanical ventilation showed substantial improvement and six ultimately left the hospital, said Dr. Jonathan Javitt, CEO of NeuroRx.
"If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need," he said.
UCI is among three sites to launch the Aviptadil clinical trial - the others being the University of Miami and Thomas Jefferson University Hospital in Philadelphia - and the only one west of the Mississippi River.
The trial will eventually grow to about 120 patients in all, with estimated completion later this year.
The Aviptadil clinical trial is among several COVID-19-related studies underway at UCI Health. On April 29, UCI Health physicians announced that trials showed that the antiviral drug remdesivir significantly slowed the progression of COVID-19. UCI Health began a clinical study of remdesivir in mid-March. A second phase of the remdesivir trial is pending.