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Proxalutamide Treatment for Hospitalized COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04728802
Recruitment Status : Completed
First Posted : January 28, 2021
Results First Posted : June 23, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Covid19
SARS (Severe Acute Respiratory Syndrome)
Interventions Drug: Proxalutamide
Drug: Placebo
Enrollment 645
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Period Title: Overall Study
Started 317 328
Completed [1] 288 292
Not Completed 29 36
Reason Not Completed
Withdrawal by Subject             4             20
Physician Decision             7             7
Protocol Violation             10             4
Transfer             1             0
Death             4             5
Other             3             0
[1]
All randomized patients were included in analysis
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care Total
Hide Arm/Group Description

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Total of all reporting groups
Overall Number of Baseline Participants 317 328 645
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 317 participants 328 participants 645 participants
50
(41 to 62)
49
(38 to 61)
50
(39 to 61.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
Female
133
  42.0%
146
  44.5%
279
  43.3%
Male
184
  58.0%
182
  55.5%
366
  56.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 317 participants 328 participants 645 participants
317 328 645
Body mass index over 30 kg/m2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
28
   8.8%
25
   7.6%
53
   8.2%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
93
  29.3%
82
  25.0%
175
  27.1%
Type 2 diabetes mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
41
  12.9%
38
  11.6%
79
  12.2%
Chronic obstructive pulmonary disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
8
   2.5%
8
   2.4%
16
   2.5%
Chronic kidney disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
0
   0.0%
0
   0.0%
0
   0.0%
0 Coexisting conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
204
  64.4%
227
  69.2%
431
  66.8%
1 Coexisting conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
68
  21.5%
56
  17.1%
124
  19.2%
2+ Coexisting conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 328 participants 645 participants
45
  14.2%
45
  13.7%
90
  14.0%
1.Primary Outcome
Title 14 Day Recovery Rate
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description:

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Overall Number of Participants Analyzed 317 328
Measure Type: Count of Participants
Unit of Measure: Participants
258
  81.4%
117
  35.7%
2.Secondary Outcome
Title 28 Day Recovery Rate
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description:

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Overall Number of Participants Analyzed 317 328
Measure Type: Count of Participants
Unit of Measure: Participants
271
  85.5%
155
  47.3%
3.Secondary Outcome
Title 28 Day Mortality Rate
Hide Description All-cause mortality rate over 28 days post randomization.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description:

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Overall Number of Participants Analyzed 317 328
Measure Type: Count of Participants
Unit of Measure: Participants
35
  11.0%
162
  49.4%
4.Secondary Outcome
Title Post-Randomization Time to Recover (Alive Hospital Discharge)
Hide Description Number of day post-randomization required to achieve live hospital discharge.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description:

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

Overall Number of Participants Analyzed 317 328
Median (Inter-Quartile Range)
Unit of Measure: Days
5
(3 to 8)
10
(6 to 15)
Time Frame 28 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
Hide Arm/Group Description

Proxalutamide + usual care as determined by care provider

Proxalutamide: Proxalutamide 300mg q.d

Placebo + usual care as determined by care provider

Placebo: Placebo pill

All-Cause Mortality
Proxalutamide + Usual Care Placebo + Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   35/317 (11.04%)   162/328 (49.39%) 
Hide Serious Adverse Events
Proxalutamide + Usual Care Placebo + Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   38/317 (11.99%)   170/328 (51.83%) 
General disorders     
Death *  35/317 (11.04%)  162/328 (49.39%) 
Respiratory, thoracic and mediastinal disorders     
Mechanical Ventilation *  5/317 (1.58%)  41/328 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Proxalutamide + Usual Care Placebo + Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   51/317 (16.09%)   11/328 (3.35%) 
Gastrointestinal disorders     
Diarrhea *  51/317 (16.09%)  11/328 (3.35%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John McCoy
Organization: Applied Biology, Inc.
Phone: +1 (949)387-4526
EMail: johnm@appliedbiology.com
Publications:
Layout table for additonal information
Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT04728802    
Other Study ID Numbers: KP-DRUG-SARS-003
First Submitted: January 27, 2021
First Posted: January 28, 2021
Results First Submitted: June 15, 2021
Results First Posted: June 23, 2021
Last Update Posted: June 24, 2021