CPhI Online

- Research & Development

SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment

7 Jul 2020

The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.

SGS 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 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 way 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 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 recruiting 50 COVID-19 positive patients who have developed severe respiratory symptoms in the last 7 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, and improvements to respiratory function and the effect on biomarkers associated with inflammation and the RAS.

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.