SGS has announced the first patient’s enrollment into an important new clinical trial designed to examine the safety, tolerability, and efficacy of a potential drug candidate for people suffering from Covid-19 related respiratory failure.
SGS was chosen by French biotech company Biophytis to conduct its COVA study – a Clinical Trial with Sarconeos (BIO101) for the treatment of patients with Covid-19 related respiratory failure. The study, which has so far received regulatory approval in Belgium, France, Brazil, the UK, and the US, will initially recruit around 50 patients who have tested positive for Covid-19 and have also developed severe respiratory symptoms in the previous seven days. They must have obvious Covid-19 symptoms – for example, pneumonia and oxygen distress – but cannot have been reliant on high-flow oxygen use or assisted ventilation during the previous 28-days.
Steven Thys, SGS’s director of Global Clinical Operations, commented, “As the whole world faces up to the challenge of finding effective treatments for Covid-19 we are pleased to announce the first patient has been successfully enrolled into the COVA Study. In the coming weeks, we may see more patients entering the study as more sites from different countries will join the study.”
“Biophytis’ decision to choose SGS as its partner in the COVA Study is testament to our considerable expertise as a contract research organization with proficiency in the field of infectious diseases. Together, we have worked intensively to set up this study in a remarkably efficient timeframe.”
SGS said, at the end of this initial 28-day trial, an Independent Data Monitoring Committee (IDMC) will conduct an interim analysis to determine whether the study should progress. The second phase could involve the recruitment of a further 260 patients. Totaling 310 patients participating in the trial.
SGS Clinical Research has over 35 years of experience in clinical research and bioanalytical testing. Able to offer phase I to IV clinical trials, they have considerable experience with infectious diseases, respiratory disease, and vaccines. SGS Clinical Research supports leading biotech and pharmaceutical companies in the design and conduct of clinical studies. By leveraging its global network of experts and clinical trial centers, SGS can optimize timelines and support study submissions, all following regulatory conditions.
Biophytis SA is a clinical-stage biotechnology company specializing in developing drug candidates to slow down degenerative processes and improve functional abilities in patients with age-related diseases, especially neuromuscular diseases.
SGS is the world’s leading inspection, verification, testing, and certification company. With more than 89,000 employees, we operate a network of more than 2,600 offices and laboratories worldwide, including India.