CX-4945-Moderate COVID-19 Study Focus CX-4945-Moderate COVID-19 Protocol Number CX4945-AV01-IIT (IND No. 152726) Sponsor Chris Recknor, MD Center for Advanced Research & Education (CARE) Estimated Enrollment 20 patients with confirmed moderate COVID-19 Objective Primary Objective: To assess safety and tolerability of CX-4945 administered orally twice daily to patients with moderate COVID-19 Secondary Objectives: To compare time to clinical recovery in CX-4945 treatment group as compared to the control arm at Day 14. To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm. To evaluate the PK of CX-4945 when given at 1000 mg orally twice daily. To evaluate the Clinical Benefit of Silmitasertib (CX-4945) relative to the control arm in patients with moderate COVID-19 To evaluate changes in inflammatory markers. Link: https://clinicaltrials.gov/ct2/show/NCT04663737?term=CX-4945&cond=COVID19&draw=2&rank=1
CX-4945-Severe COVID-19 Study Focus CX-4945-Severe COVID-19 Protocol Number CX4945-AV02-IIT (IND No. 153620) Sponsor Marilyn Glassberg Csete, MD Banner Health-University Medical Center in Phoenix, Arizona (BUMCP) Estimated Enrollment 40 patients with confirmed severe COVID-19 Objective Primary Objective: To assess safety and tolerability of CX-4945 administered orally twice daily to patients with severe COVID-19 Secondary Objectives: To compare time to clinical recovery in CX-4945 treatment group evaluated from randomization through Day 28 as compared to the control arm. To compare changes in clinical status of patients enrolled to CX-4945 treatment arm as compared to the control arm at Day 14 and Day 28. To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm. To evaluate the Clinical Benefit of Silmitasertib (CX-4945) relative to the control arm in patients with Severe COVID-19. To evaluate changes in inflammatory markers Link: https://clinicaltrials.gov/ct2/show/NCT04668209?term=cx-4945&draw=2&rank=1
