SGS has received approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to initiate a clinical trial of a potential treatment for patients with COVID-19 related respiratory failure. The COVA study – a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure, is being sponsored by Biophytis.
The trial will look at how Sarconeos (BIO101) helps to inhibit the development of Acute Respiratory Distress Syndrome (ARDS) by activating the mitochondrial assembly (Mas) receptor, a key component of the protective arm of the renin angiotensin system (RAS), which regulates respiratory function.
SGS will conduct the clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, in Belgium.
Stage one of the two-part COVA study involves the recruitment of 50 COVID-19 positive patients who have developed severe respiratory symptoms in the last seven days. These patients must display common COVID-19 symptoms and have pneumonia and oxygen distress.
The trial will evaluate Sarconeos (BIO101) by looking at safety and tolerability and improvements to respiratory function and the effect on biomarkers associated with inflammation and the RAS.
Steven Thys, SGS’s Director of Global Clinical Operations said, “We are very excited to open the first trial site in Belgium and look forward to enrolling patients in the coming weeks.” He continued, “We have been working intensively with our partners at AZ Sint-Maarten and Biophytis to get this COVA study started as quickly as possible. The positive and fast approval given by FAMHP is the result of excellent teamwork and demonstrates our commitment to supporting biotech companies such as Biophytis as it advances its research into new therapies against COVID-19.”