The purpose of this study is to assess the efficacy and safety of Proxalutamide as a treatment for hospitalized COVID-19 male and female patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
645
Proxalutamide 300mg q.d
Placebo pill
Hospital Regional José Mendes
Itacoatiara, Amazonas, Brazil
Hospital de Campanha de Manacapuru
Manacapuru, Amazonas, Brazil
Hospital Oscar Nicolau
Manaus, Amazonas, Brazil
Hospital Prontocord
Manaus, Amazonas, Brazil
14 Day Recovery Rate
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
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
28 Day Mortality Rate
All-cause mortality rate over 28 days post randomization.
Time frame: 28 days
Post-Randomization Time to Recover (Alive Hospital Discharge)
Number of day post-randomization required to achieve live hospital discharge.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Samel
Manaus, Amazonas, Brazil
Hospital Regional Dr. Hamilton Maia Cidae
Manicoré, Amazonas, Brazil
Hospital Raimunda Francisca Dinelli da Silva
Maués, Amazonas, Brazil
Hospital Regional Jofre Cohen
Parintins, Amazonas, Brazil