The trial will examine a drug candidate for COVID-19 related acute respiratory failure treatment
SGS, a leading contract research organization (CRO) with more than 35 years of experience in clinical research and bioanalytical testing, is pleased to announce the enrolment of the first patient into Biophytis COVA clinical study.
The study is an important new clinical trial designed to examine the safety, tolerability and efficacy of a potential drug candidate for people suffering with 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 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 – such as 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 organisation with proficiency in the field of infectious diseases. Together, we have worked intensively to set up this study in a remarkably efficient timeframe.”
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, totalling 310 patients participating in the trial.