The company aims to recruit a total of 310 participants for the Phase II/III study
SGS has announced the recruitment of the first participants in the US who will be taking part in a multinational clinical trial of a potential drug candidate for those suffering with COVID-19 related respiratory failure.
This follows the company’s recent announcement of its selection by French biotech company Biophytis for its COVA study – a clinical trial with Sarconeos (BIO101) for the treatment of COVID-19 related respiratory failure.
It will recruit 310 participants for a maximum 28-day treatment in this Phase II/III trial which will examine the drug’s safety, tolerability, and efficacy. All participants must have been tested positive for COVID-19, developed severe respiratory symptoms and show COVID-19 symptoms.
The study has received regulatory approval in Belgium, France, Brazil, the UK, and US. Recruitment occurs in two parts, the first with 50 participants, at the end of which, an independent data monitoring committee will conduct an interim analysis to determine whether the study should progress. The second part will recruit an additional 260 participants, totalling 310 participants participating in the Phase II/III trial.
Joanne Zephirin, Clinical Research Associate Manager in the US, said: “As experts in clinical research services, our US team is very proud to partner with Biophytis on its COVA trial and we welcome the first participants to the study. Our involvement in this important trial is testament to the quality of our clinical trial management services, and proficiency in the field of infectious diseases, which supports organizations around the globe to bring new therapies to market safely and quickly.”