OCT Clinical, a European CRO, has obtained a CTA approval to run a Ph3 pulmonology study.
This is a multicenter, double-blind, randomized, placebo-controlled study that will be conducted in parallel groups. The aim of the study is to evaluate the efficacy and safety of a drug compared with a placebo in patients suffering from lung abnormalities following COVID-19 infection.
According to the study Protocol, 392 adults are to be enrolled for a 5-day therapy with 3 courses of injection. The patients will be recruited at 25 research sites.
Among the key challenges observed by the supervising project manager from OCT Clinical is the fact that with the overall numbers of COVID-19 infections going down rapidly there is a noticeable difficulty in finding patients with the right diagnosis. But due to extensive experience of the clinical team in the field and access to a wide range of research clinical, the OCT is positive of the favorable outcome in terms of recruitment goals.
Within the project,the OCT Clinical team is responsible for medical writing, project management, monitoring, data management, statistics, and logistics.
