SGS is pleased to announce 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.
The recruitment follows SGS’s recent announcement of its selection by French biotech company Biophytis to conduct its COVA study – a Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure.
In total, SGS will recruit 310 participants for a maximum 28-day treatment in this Phase 2/3 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 2 parts, the first with 50 participants, at the end of which, an Independent Data Monitoring Committee (IDMC) will conduct an interim analysis to determine whether the study should progress. The second part will recruit an additional 260 participants, totaling 310 participants participating in the Phase 2/3 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.”
SGS CLINICAL TRIAL MANAGEMENT SERVICES
With over 40 years experience as a full-service contract research organization, SGS’s Clinical Trial Management Services provide a wide range of integrated services across the US and Europe – from drug development consultancy activities to Phase 1-4 trial management, as well as bioanalytical and QC testing – and has considerable experience with infectious diseases, respiratory disease, and vaccines.
Organizations benefit from SGS’s unrivaled expertise in international project management and clinical monitoring, providing a global network of therapeutic-specific key opinion leaders, subject-matter experts and pre-qualified investigator trial sites. The company also provides regulatory guidance and regulatory IND/NDA submission experience in the US, Canada and Europe, along with expertise in drug import regulations and procedures for every country in Europe and North America.
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 in accordance with regulatory conditions.