Mechelen, Belgium July 7, 2020: SGS, the world’s leading inspection, verification, testing and certification company, has received approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) and has initiated the first site to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.
The trial is entitled, ‘COVA study – a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure’. It is being conducted by French biotech company Biophytis that has selected SGS because of its extensive experience as a full-service contract research organization (CRO) with considerable expertise in the field of infectious diseases.
One of the ways Coronavirus SARS-Cov-2 causes Acute Respiratory Distress Syndrome (ARDS) is by disrupting the renin angiotensin system (RAS), which regulates respiratory function. The trial will look at how Sarconeos (BIO101) helps to inhibit the development of ARDS by activating the mitochondrial assembly (Mas) receptor, a key component of the protective arm of the RAS.
SGS will undertake this pivotal clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, under the co-ordination of Dr Muriel Lins, Pneumologist and Principal Investigator of COVA 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 not accept patients who have required high-flow oxygen use or assisted ventilation during the previous 28 days.
The trial will evaluate Sarconeos (BIO101) by looking at:
- Safety and tolerability
- Improvements to respiratory function and the effect on biomarkers associated with inflammation and the RAS
Steven Thys, SGS’s Director of Global Clinical Operations commented, “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.”
The initial 28-day trial will be followed by interim analysis conducted by an independent data monitoring committee (IDMC). This will provide preliminary data on the efficacy of Sarconeos (BIO101) to prevent the deterioration of respiratory function in COVID-19 patients. The IDMC will also determine whether the COVA trial should progress into stage two, which would involve enrolling at least 540 COVID-19 patients for evaluation against the same criteria as stage one.
About SGS Clinical Research Services
SGS Clinical Research is a CRO offering clinical research services and bioanalytical testing for Phase 1 to 4 clinical trials, with a specialization in infectious diseases, respiratory disease and vaccines. As the leading CRO in the life science industry with over 35 years’ experience in clinical research, SGS is perfectly placed to support biotech and pharmaceutical companies in designing and conducting clinical studies. SGS helps optimize timelines and supports the submission of the studies according to the regulations, with the aim of bringing products to market in a fast and safe way.
SGS Clinical Research has its own Phase 1 unit in Antwerp that incorporates a ‘viral challenge testing’ department. It also has a network of Phase 1 patient units in Hungary and Belgium, including the unit at AZ Sint Maarten.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.