Trial Outcomes & Findings for Proxalutamide Treatment for Hospitalized COVID-19 Patients (NCT NCT04728802)

Last Updated: 2021-06-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

645 participants

Primary outcome timeframe

Day 14

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Proxalutamide + Usual Care Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care Placebo + usual care as determined by care provider Placebo: Placebo pill
Overall Study STARTED	317	328
Overall Study COMPLETED	288	292
Overall Study NOT COMPLETED	29	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Proxalutamide + Usual Care Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care Placebo + usual care as determined by care provider Placebo: Placebo pill
Overall Study Withdrawal by Subject	4	20
Overall Study Physician Decision	7	7
Overall Study Protocol Violation	10	4
Overall Study Transfer	1	0
Overall Study Death	4	5
Overall Study Other	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proxalutamide + Usual Care n=317 Participants Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 Participants Placebo + usual care as determined by care provider Placebo: Placebo pill	Total n=645 Participants Total of all reporting groups
Age, Continuous	50 years n=317 Participants	49 years n=328 Participants	50 years n=645 Participants
Sex: Female, Male Female	133 Participants n=317 Participants	146 Participants n=328 Participants	279 Participants n=645 Participants
Sex: Female, Male Male	184 Participants n=317 Participants	182 Participants n=328 Participants	366 Participants n=645 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	317 participants n=317 Participants	328 participants n=328 Participants	645 participants n=645 Participants
Body mass index over 30 kg/m2	28 Participants n=317 Participants	25 Participants n=328 Participants	53 Participants n=645 Participants
Hypertension	93 Participants n=317 Participants	82 Participants n=328 Participants	175 Participants n=645 Participants
Type 2 diabetes mellitus	41 Participants n=317 Participants	38 Participants n=328 Participants	79 Participants n=645 Participants
Chronic obstructive pulmonary disorder	8 Participants n=317 Participants	8 Participants n=328 Participants	16 Participants n=645 Participants
Chronic kidney disease	0 Participants n=317 Participants	0 Participants n=328 Participants	0 Participants n=645 Participants
0 Coexisting conditions	204 Participants n=317 Participants	227 Participants n=328 Participants	431 Participants n=645 Participants
1 Coexisting conditions	68 Participants n=317 Participants	56 Participants n=328 Participants	124 Participants n=645 Participants
2+ Coexisting conditions	45 Participants n=317 Participants	45 Participants n=328 Participants	90 Participants n=645 Participants

PRIMARY outcome

Timeframe: Day 14

Outcome measures

Outcome measures
Measure	Proxalutamide + Usual Care n=317 Participants Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 Participants Placebo + usual care as determined by care provider Placebo: Placebo pill
14 Day Recovery Rate	258 Participants	117 Participants

SECONDARY outcome

Timeframe: Day 28

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

Outcome measures

Outcome measures
Measure	Proxalutamide + Usual Care n=317 Participants Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 Participants Placebo + usual care as determined by care provider Placebo: Placebo pill
28 Day Recovery Rate	271 Participants	155 Participants

SECONDARY outcome

Timeframe: 28 days

All-cause mortality rate over 28 days post randomization.

Outcome measures

Outcome measures
Measure	Proxalutamide + Usual Care n=317 Participants Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 Participants Placebo + usual care as determined by care provider Placebo: Placebo pill
28 Day Mortality Rate	35 Participants	162 Participants

SECONDARY outcome

Timeframe: 28 days

Number of day post-randomization required to achieve live hospital discharge.

Outcome measures

Outcome measures
Measure	Proxalutamide + Usual Care n=317 Participants Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 Participants Placebo + usual care as determined by care provider Placebo: Placebo pill
Post-Randomization Time to Recover (Alive Hospital Discharge)	5 Days Interval 3.0 to 8.0	10 Days Interval 6.0 to 15.0

Adverse Events

Proxalutamide + Usual Care

Serious events: 38 serious events

Other events: 51 other events

Deaths: 35 deaths

Placebo + Usual Care

Serious events: 170 serious events

Other events: 11 other events

Deaths: 162 deaths

Serious adverse events

Serious adverse events
Measure	Proxalutamide + Usual Care n=317 participants at risk Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 participants at risk Placebo + usual care as determined by care provider Placebo: Placebo pill
General disorders Death	11.0% 35/317 • 28 Days	49.4% 162/328 • 28 Days
Respiratory, thoracic and mediastinal disorders Mechanical Ventilation	1.6% 5/317 • 28 Days	12.5% 41/328 • 28 Days

Other adverse events

Other adverse events
Measure	Proxalutamide + Usual Care n=317 participants at risk Proxalutamide + usual care as determined by care provider Proxalutamide: Proxalutamide 300mg q.d	Placebo + Usual Care n=328 participants at risk Placebo + usual care as determined by care provider Placebo: Placebo pill
Gastrointestinal disorders Diarrhea	16.1% 51/317 • 28 Days	3.4% 11/328 • 28 Days

Additional Information

Dr. John McCoy

Applied Biology, Inc.

Phone: +1 (949)387-4526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place