The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
133
Proxalutamide 300mg q.d.(3 tablets of 100mg each) for 14 days.
Placebo 3 tablets q.d. for 14 days
Corpometria Institute
Brasília, Federal District, Brazil
14-Day Recovery Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 14 days after randomization on the COVID-19 ordinal scale. The ordinal scale is defined as follows: 8\. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities
Time frame: Day 14
28-Day Recovery Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 28 days after randomization on the COVID-19 ordinal scale. The ordinal scale is defined as follows: 8\. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities
Time frame: Day 28
14-Day All-Cause Mortality Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by all-cause mortality rate over 14 days post randomization.
Time frame: Day 14
28-Day All-Cause Mortality Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by all-cause mortality rate over 28 days post randomization.
Time frame: Day 28
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Post-Randomization Time to Recover (Alive Hospital Discharge)
Treatment efficacy of proxalutamide relative to placebo as assessed by number of day post-randomization required to achieve live hospital discharge.
Time frame: Day 28
Proportion of subjects needing potent, large-spectrum antibiotics
Defined as the number of subjects who have required vancomycin, meropenem or polymyxin B allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of proxalutamide relative to placebo arm as assessed by the proportion of subjects needing vancomycin, meropenem or polymyxin B in each arm. (%)
Time frame: Day 28
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Treatment efficacy of proxalutamide relative to placebo arm as assessed by the rate between the percentage of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 7 after randomization allocated in each arm.
Time frame: Day 7
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
Treatment efficacy of proxalutamide relative to placebo arm as assessed by the rate between the percentage of subjects presenting increased d-dimer at Day 7 after randomization allocated in each arm.
Time frame: Day 7