Name (Synonyms) | Correlation | |
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drug3329 | mHealth Assessments Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
This multi-center, double-blind, placebo-controlled, randomized Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in approximately 400-440 patients hospitalized with confirmed COVID-19. The Phase 2 portion of the trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. The Phase 3 portion of the trial will include approximately 360-400 additional patients, and is designed to determine whether bardoxolone methyl increases the probability of recovery at Day 29 when compared with matching placebo. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.
Description: Recovery is defined as alive, free of respiratory failure (e.g., need for noninvasive, or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of renal replacement therapy (RRT).
Measure: Proportion of participants who have recovered in Phase 3 Time: Day 29Description: Deterioration is defined by a 1-point worsening scale: 0- Uninfected; no viral RNA detected, 1- Asymptomatic; viral RNA detected, 2- Symptomatic; Independent, 3- Symptomatic; assistance needed, 4- Hospitalized; no oxygen therapy, 5- Hospitalized; oxygen by mask or nasal prongs, 6- Hospitalized; oxygen by NIV or High flow, 7- Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200, 8- Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors, 9- Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO, 10- Death
Measure: Proportion of participants who experienced deterioration from baseline Time: Day 29