New in ScienceTM: A Phase 2a clinical trial of Molnupiravir in patients with COVID19 shows accelerated SARSCoV2 RNA clearance and elimination of infectious virus.
). Samples were considered positive if the supernatant had at least 1,000 copies/mL SARS-CoV-2 RNA at 2 days post inoculation or if the relative fold-change in RNA copy number from culture days 2 to 5 post inoculation was >5. The criteria for positivity were created based on preliminary studies and recombinant virus controls of 50 PFU and 500 PFU included for every batch of clinical samples.
The primary endpoint was evaluated a priori using a Kaplan-Meier estimation with a corresponding exact log-rank test. Anticipating up to 10% missing data, 44 participants provided 88% power to detect a risk difference of -35% in the primary endpoint using a type I error rate of 0.10. The sample size in the dose escalation part was based on assessment of the primary endpoint across all parts.