Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by viral load measured by positivity rate (% of positive, detected rtSARS-CoV-2) |
Day 7 |
|
Secondary |
World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death] |
Treatment efficacy of dutasteride relative to placebo arm as assessed by World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death] |
Day 14 |
|
Secondary |
World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death] |
Treatment efficacy of dutasteride relative to placebo arm as assessed by World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death] |
Day 7 |
|
Secondary |
Time-to-recovery |
Recovery is defined as the first day on which the subject satisfies category one from the COVID ordinal scale (defined in Section 5.1): (1) Not hospitalized, no limitations on activities. [Parameter: Number of days until achieve Category 1 of the World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death] |
Day 28 |
|
Secondary |
SARS-CoV-2 viral load |
Treatment efficacy dutasteride relative to placebo arm as assessed by viral load measured by rtPCR-SARS-CoV-2 (CTs) |
Day 5 |
|
Secondary |
Duration of fatigue |
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of fatigue (days) |
Day 14 |
|
Secondary |
Duration of anosmia |
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of anosmia (days) |
Day 14 |
|
Secondary |
Overall duration of clinical manifestations |
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of overall symptoms (days) |
Day 14 |
|
Secondary |
Proportion of subjects needing additional drugs or interventions |
Defined as the number of subjects who have required additional drugs (glucocorticoids, anticoagulants, etc) or interventions allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy dutasteride relative to placebo arm as assessed by the proportion of subjects needing additional drugs or interventions in each arm. (%) |
Day 28 |
|
Secondary |
Proportion of subjects needing oxygen use |
Defined as the number of subjects who have required oxygen use allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of subjects needing oxygen use in each arm. (%) |
Day 28 |
|
Secondary |
Proportion of subjects needing high-flow oxygen therapy or non-invasive ventilation |
Defined as the number of subjects who have required high-flow oxygen use or non-invasive mechanical ventilation allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of subjects needing high-flow oxygen use or non-invasive mechanical ventilation in each arm. |
Day 28 |
|
Secondary |
Proportion of hospitalizations |
Defined as the number of hospitalizations in each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of hospitalizations in each arm. |
Day 28 |
|
Secondary |
Proportion of mechanical ventilation use |
Defined as the number of subjects that needed mechanical ventilation in each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of mechanical ventilation use in each arm divided by the number of subjects randomized to that specific arm. |
Day 28 |
|
Secondary |
Proportion of vasopressors use |
Defined as the number of subjects that needed vasopressors use in each arm divided by the number of subjects randomized to that specific arm (%).Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects needing use of pressors in each arm divided by the number of subjects randomized to that specific arm. |
Day 28 |
|
Secondary |
Proportion of deaths |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects who have died in each arm divided by the numbers of subjects randomized to the treatment arm (%). |
Day 60 |
|
Secondary |
Duration of new oxygen use |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of new oxygen use measured in days among subjects that did not require oxygen upon randomization and required oxygen use after the beginning of treatment, in each arm (days) |
Day 28 |
|
Secondary |
Duration of hospitalization |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of hospitalization measured in days among subjects that required hospitalization, in each arm (days) |
Day 28 |
|
Secondary |
Duration of mechanical ventilation |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of mechanical ventilation measured in days among subjects that required mechanical ventilation, in each arm (days) |
Day 28 |
|
Secondary |
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 1, divided by the number of subjects randomized to that specific arm (%). |
Day 1 |
|
Secondary |
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 3, divided by the number of subjects randomized to that specific arm (%). |
Day 3 |
|
Secondary |
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 7, divided by the number of subjects randomized to that specific arm (%). |
Day 7 |
|
Secondary |
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 1, divided by the number of subjects randomized to that specific arm (%). |
Day 1 |
|
Secondary |
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 3, divided by the number of subjects randomized to that specific arm (%). |
Day 3 |
|
Secondary |
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 7, divided by the number of subjects randomized to that specific arm (%). |
Day 7 |
|
Secondary |
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 1, divided by the number of subjects randomized to that specific arm (%). |
Day 1 |
|
Secondary |
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 3, divided by the number of subjects randomized to that specific arm (%). |
Day 3 |
|
Secondary |
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0)) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 7, divided by the number of subjects randomized to that specific arm (%). |
Day 7 |
|
Secondary |
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased d-dimer protein (usCRP) at Day 7, divided by the number of subjects randomized to that specific arm (%). |
Day 7 |
|
Secondary |
Variation in oxygen saturation compared to baseline (Day 0) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 1 compared to baseline (Day 0). |
Day 1 |
|
Secondary |
Variation in oxygen saturation compared to baseline (Day 0) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 3 compared to baseline (Day 0). |
Day 3 |
|
Secondary |
Variation in oxygen saturation compared to baseline (Day 0) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 5 compared to baseline (Day 0). |
Day 5 |
|
Secondary |
Variation in oxygen saturation compared to baseline (Day 0) |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 7 compared to baseline (Day 0). |
Day 7 |
|
Secondary |
Disease duration |
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of symptoms, complications, or any other COVID-related clinical or biochemical sign of disease (days) |
Day 30 |
|
Secondary |
Change in viral load from baseline to Day 5 |
Treatment efficacy of dutasteride relative to placebo arm as assessed by change in viral load from baseline to Day 5 measured by rtPCR-SARS-CoV-2 (CTs) |
Day 5 |
|
Secondary |
Proportion of post-COVID mental symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30. |
Day 30 |
|
Secondary |
Proportion of post-COVID physical symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30. |
Day 30 |
|
Secondary |
Proportion of post-COVID overall symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30. |
Day 30 |
|
Secondary |
Proportion of post-COVID mental symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60. |
Day 60 |
|
Secondary |
Proportion of post-COVID physical symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60. |
Day 60 |
|
Secondary |
Proportion of post-COVID overall symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60. |
Day 60 |
|
Secondary |
Proportion of post-COVID mental symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90. |
Day 90 |
|
Secondary |
Proportion of post-COVID physical symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90. |
Day 90 |
|
Secondary |
Proportion of post-COVID overall symptoms |
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90. |
Day 90 |
|