There is one clinical trial.
The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the
treatment of patients infected with COVID-19. This Protocol is largely based on the
recommendations of the WHO R&D Blueprint Clinical Trials Expert Group COVID-19 Therapeutic
Trial Synopsis, and associated Master Protocol.
The choice of the primary outcome measure will be determined by a pilot study of the first
150 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment
versus the control group is the default primary endpoint.
Primary Outcomes
Description: Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or ECMO
Death
Measure: Patient clinical status (on the WHO 7-point ordinal scale) at day 15 in IP versus SOC control group patients:
Time: Day 15
Secondary Outcomes
Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 28 in IP versus control group patients Time: Days 1 through 28
Measure: NEWS assessed days 3, 5, 8 ,11 daily while hospitalized and on days 15 and 29 in IP versus control group patients Time: Days 3, 5, 8, 11, 25, 29
Measure: Rate of mechanical ventilation in IP versus control group patients Time: Day 15, 28
Measure: Duration of mechanical ventilation (if applicable) in IP versus control group patients Time: Day 15, 28
Measure: Duration of supplemental oxygen in IP versus control group patients Time: Day 15, 28
Measure: Time to return to room pressure (SpO2 > 94%) on room air Time: Day 15, 28
Measure: Duration in ICU (if applicable) in IP versus control group patients Time: Day 15, 28
Measure: Rate of Mortality in IP versus control group patients Time: Day 15, 28
Measure: Duration of hospitalization in IP versus control group patients Time: Day 15, 28
Measure: Time to discharge in IP versus control group patients Time: Day 15, 28
Measure: Effect on the rate of change of partial pressure of oxygen (PaO2) and PaO2/FiO2 ratio taken at baseline and measured once daily up to 2 weeks of treatment in IP versus control group patients Time: Up to day 15, day 28