Farma

Yngling ØH
23.01.2021 kl 00:13 3543

Her er den relevante informasjonen:

9.3 Sample Size Determination The study consists of two parts: Stage 1 (pilot stage) and Stage 2 (confirmatory stage). Stage 1 (Pilot Stage) This stage will focus on assessing a number of candidate agents with SoC, with the aim of carrying forward a subset of candidate agents into Stage 2, the confirmatory stage. Approximately 60 patients will be randomised into each arm at this stage of the study, whereby patients will receive either one of the candidate agents (with SoC) or SoC alone. The chosen endpoint to compare treatments will be the time to a 2-point improvement on a 9-point category ordinal scale, discharge from hospital, or considered fit for discharge. Based on the chosen endpoint, a preliminary analysis will be carried out when an estimated 81 events have been observed across each agent treatment and SoC or 28 days after the last patient has been randomised, whichever occurs sooner, as determined by the IDMC. In order to achieve this number of events, it is expected that 54 patients are needed per arm, which will provide 80% power to detect a hazard ratio of 1.6 for the occurrence of the event, when comparing each candidate agent with SoC. This calculation is based on a 1-sided test and a 10% significance level, and assumes 85.5% of patients will improve, be discharged from hospital, or considered fit for discharge at Day 29 for a candidate treatment versus 70% of patients for the SoC (the estimate of SoC was taken from Cao 20204). To allow for uncertainty in the recruitment rates, it is expected that up to 60 patients (rather than 54 patients) will be randomised to each arm in order to achieve the required number of events for the preliminary analysis. Safety data will also be assessed.

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