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 which 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 renin-angiotensin system (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:
SGS’s Director of Global Clinical Operations Steven Thys 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.