ACTIV IV ACUTE: Anti-thrombotics for Adults Hospitalized With COVID-19
Agent A VS. Agent B (reference)
Adults hospitalized for COVID-19 and expected to remain in hospital longer than 72 hours.
Therapeutic heparin above standard of care or standard of care prophylactic dose of heparin.
Up to 1,000 per arm as arms are added.
Power and Interim Assessments
Power is dependent on sample size. Some generic calculations:
- 1,000 vs. 1,000 will have 80% power for an odds ratio change of 1.25
- 400 vs. 400 will have 90% power for and odds ratio change of 1.5
- 200 vs 200 will have 90% power for an odds ratio change of 2.0
Interim analysis at 20, 40, 60, 80 and 100 percent enrollment.
Earliest Day 28 or hospital discharge with potential contact up to 1 year after discharge.