NECTAR: Novel Experimental COVID Therapies Affecting Host Response
Agent A v. Placebo; Agent B v. Placebo
Adult patients hospitalized for COVID-19 with laboratory confirmed SARS-CoV-2 infection and treated with oxygen for hypoxemia
TXA127, TRV027, APN01, and Placebo arm
1,600 total; 300 per arm + ~400 for common placebo
Power and Interim Assessments
For each arm, we will use pre-planned interim analyses at fixed recruitment intervals to consider ending enrollment early due to strong evidence of inferiority or futility regarding the primary efficacy analysis. Early stopping and final analysis thresholds will be selected to ensure a type-I error probability of 2.5%, separately for each study agent.
Two planned interim analyses will occur at 33% (100 participants in both the active and matching placebo group have completed 28-day follow-up) and 66% of maximum enrollment for each arm. Prior to the first interim analysis, sample size adequacy will be re-assessed based on the pooled (across all active and placebo arms) distribution of the primary outcome.
A maximum sample size of 300 participants per arm (and matching placebo) provides over 85% power to detect an odds ratio of 1.55, corresponding to a 2.3-day difference in mean OFDs.
Duration of hospitalization with post-discharge follow-up for up to 90 days after randomization. Participants may be contacted beyond 90 days for long-term follow-up.