UCI Health will initiate a clinical study of a drug to treat patients critically ill with coronavirus who face a high mortality rate because of acute inflammation that fills their lungs with fluid.
This is a grave condition that cannot be improved, even through mechanical ventilation.
Aviptadil has a history of use in human clinical trials for lung ailments.
In the current trial, which would be conducted by UCI Health, the drug will be employed in a Phase IIb/III clinical study of Covid-19 patients suffering from acute respiratory distress syndrome (ARDS), one of the primary causes of coronavirus-induced death.
Aviptadil clinical trial principal investigator Richard Lee said: “We’re very pleased to be one of the first centres 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.”
In Europe, the drug is available as a Vasoactive Intestinal Polypeptide (VIP) formulation to treat erectile dysfunction.
Death among Covid-19 patients is known to be partly caused by a ‘cytokine storm’ in the lungs, where the virus induces inflammatory molecules called ‘cytokines’.
Cytokines cause the air sacs of the lungs to fill with water, making the sacs impermeable to oxygen, even with mechanical ventilation.
NeuroRx CEO Jonathan Javitt said: NeuroRx Inc, Relief Therapeutics’ US 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.
“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.”
Earlier this month, Relief Therapeutics said it is conducting a US Food and Drug Administration (FDA)-approved Phase II clinical trial at New York University Langone (NYU Langone Health) to assess Aviptadil for Covid-19-related ARDS.