Trial Outcomes & Findings for Anti-Androgen Treatment for COVID-19 (NCT NCT04446429)
NCT ID: NCT04446429
Last Updated: 2021-12-10
Results Overview
Percentage of subjects hospitalized due to COVID-19
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
268 participants
Primary outcome timeframe
30 days
Results posted on
2021-12-10
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual care as determined by the PI
Usualf Care: Care as determined by the PI
|
Proxalutamide + Usual Care
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
134
|
|
Overall Study
COMPLETED
|
128
|
134
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Usual Care
Usual care as determined by the PI
Usualf Care: Care as determined by the PI
|
Proxalutamide + Usual Care
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
Baseline Characteristics
Anti-Androgen Treatment for COVID-19
Baseline characteristics by cohort
| Measure |
Usual Care
n=134 Participants
Usual care as determined by the PI
Usual Care: Care as determined by the PI
|
Proxalutamide + Usual Care
n=134 Participants
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 14 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed ethnicity (Brazil)
|
134 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
134 participants
n=5 Participants
|
134 participants
n=7 Participants
|
268 participants
n=5 Participants
|
|
Coexisting conditions
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All randomized patients were included. 6 patients from the placebo arm lost to follow-up were assumed to be non-hospitalized (COVID-19 8-point ordinal scale 1) and were included in the intention-to-treat analysis.
Percentage of subjects hospitalized due to COVID-19
Outcome measures
| Measure |
Usual Care
n=134 Participants
Usual care as determined by the PI
Usual Care: Care as determined by the PI
|
Proxalutamide + Usual Care
n=134 Participants
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
|---|---|---|
|
COVID-19 Hospitalization
|
35 Participants
|
3 Participants
|
Adverse Events
Usual Care
Serious events: 35 serious events
Other events: 78 other events
Deaths: 2 deaths
Proxalutamide + Usual Care
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=134 participants at risk
Usual care as determined by the PI
Usual Care: Care as determined by the PI
|
Proxalutamide + Usual Care
n=134 participants at risk
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
1.5%
2/134 • Number of events 2 • 30 days
|
0.00%
0/134 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
26.1%
35/134 • Number of events 35 • 30 days
|
2.2%
3/134 • Number of events 3 • 30 days
|
Other adverse events
| Measure |
Usual Care
n=134 participants at risk
Usual care as determined by the PI
Usual Care: Care as determined by the PI
|
Proxalutamide + Usual Care
n=134 participants at risk
Proxalutamide + usual care as determined by the PI
Proxalutamide: 200 mg q.d.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.9%
20/134 • 30 days
|
29.1%
39/134 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
11.2%
15/134 • 30 days
|
15.7%
21/134 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain or discomfort
|
13.4%
18/134 • 30 days
|
16.4%
22/134 • 30 days
|
|
Gastrointestinal disorders
Dyspepsia or Heartburn
|
4.5%
6/134 • 30 days
|
17.2%
23/134 • 30 days
|
|
General disorders
Fatigue
|
53.0%
71/134 • 30 days
|
0.75%
1/134 • 30 days
|
|
General disorders
Fever
|
25.4%
34/134 • 30 days
|
1.5%
2/134 • 30 days
|
|
General disorders
Disease progression
|
32.1%
43/134 • 30 days
|
3.0%
4/134 • 30 days
|
|
Cardiac disorders
Tachycardia
|
33.6%
45/134 • 30 days
|
4.5%
6/134 • 30 days
|
|
Nervous system disorders
Ageusia
|
17.2%
23/134 • 30 days
|
9.7%
13/134 • 30 days
|
|
Nervous system disorders
Anosmia
|
19.4%
26/134 • 30 days
|
10.4%
14/134 • 30 days
|
|
Nervous system disorders
Headache
|
9.0%
12/134 • 30 days
|
0.75%
1/134 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.9%
36/134 • 30 days
|
11.9%
16/134 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
29.9%
40/134 • 30 days
|
3.0%
4/134 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place