Clincosm LogoSign in Get a demo

Proxalutamide Treatment for Hospitalized COVID-19 Patients

Sponsor
Applied Biology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04728802
Collaborator
(none)
645
Enrollment
8
Locations
2
Arms
2.4
Actual Duration (Months)
80.6
Patients Per Site
33.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
645 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.
Masking:
Double (Participant, Care Provider)
Masking Description:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Proxalutamide Treatment for Hospitalized COVID-19 Patients
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
Apr 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Proxalutamide + Usual Care

Proxalutamide + usual care as determined by care provider

Drug: Proxalutamide
Proxalutamide 300mg q.d
Placebo Comparator: Placebo + Usual Care

Placebo + usual care as determined by care provider

Drug: Placebo
Placebo pill

Outcome Measures

Primary Outcome Measures

  1. 14 Day Recovery Rate [Day 14]

    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

Secondary Outcome Measures

  1. 28 Day Recovery Rate [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

  2. 28 Day Mortality Rate [28 days]

    All-cause mortality rate over 28 days post randomization.

  3. Post-Randomization Time to Recover (Alive Hospital Discharge) [28 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Admitted to the hospital with symptoms of COVID-19

  2. Male and females age ≥18 years old

  3. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization

  4. Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 3, 4, 5, or 6

  5. Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN

  6. Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures

  7. Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study

Exclusion Criteria:

  1. Subject enrolled in a study to investigate a treatment for COVID-19

  2. Requires mechanical ventilation

  3. Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…

  4. Patients who are allergic to the investigational product or similar drugs (or any excipients);

  5. Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type

  6. Subjects with known serious cardiovascular diseases, congenital long QT syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular ejection fraction (LVEF) < 50%, QTcF > 450 ms

  7. Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)

  8. Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory）

  9. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.

  10. Estimated glomerular filtration rate (eGFR) < 30 ml/min

  11. Severe kidney disease requiring dialysis

  12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include:

  • Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or

  • Use of one of the following combinations (a+b or a+c or b+c):

  1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.

  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) ;

  3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository ;

  • Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment ;

  • Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient;

  • In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of child bearing potential;

  1. Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping GT0918 treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

  2. Subject likely to transfer to another hospital within the next 28 days

  3. Subject (or legally authorized representative) not willing or unable to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Regional José Mendes Itacoatiara Amazonas Brazil
2 Hospital de Campanha de Manacapuru Manacapuru Amazonas Brazil
3 Hospital Oscar Nicolau Manaus Amazonas Brazil
4 Hospital Prontocord Manaus Amazonas Brazil
5 Hospital Samel Manaus Amazonas Brazil
6 Hospital Regional Dr. Hamilton Maia Cidae Manicore Amazonas Brazil
7 Hospital Raimunda Francisca Dinelli da Silva Maues Amazonas Brazil
8 Hospital Regional Jofre Cohen Parintins Amazonas Brazil

Sponsors and Collaborators

  • Applied Biology, Inc.

Investigators

  • Principal Investigator: Flavio Cadegiani, MD, Applied Biology, Inc.
  • Study Director: Andy Goren, MD, Applied Biology, Inc.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Applied Biology, Inc.
ClinicalTrials.gov Identifier:
NCT04728802
Other Study ID Numbers:
  • KP-DRUG-SARS-003
First Posted:
Jan 28, 2021
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Applied Biology, Inc.
Proxalutamide
Androgen
Anti-androgen
Additional relevant MeSH terms:
COVID-19
Severe Acute Respiratory Syndrome

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
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 288 292
NOT COMPLETED 29 36

Baseline Characteristics

Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care Total
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 Participants 317 328 645
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
50
49
50
Sex: Female, Male (Count of Participants)
Female
133
42%
146
44.5%
279
43.3%
Male
184
58%
182
55.5%
366
56.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
Brazil
317
100%
328
100%
645
100%
Body mass index over 30 kg/m2 (Count of Participants)
Count of Participants [Participants]
28
8.8%
25
7.6%
53
8.2%
Hypertension (Count of Participants)
Count of Participants [Participants]
93
29.3%
82
25%
175
27.1%
Type 2 diabetes mellitus (Count of Participants)
Count of Participants [Participants]
41
12.9%
38
11.6%
79
12.2%
Chronic obstructive pulmonary disorder (Count of Participants)
Count of Participants [Participants]
8
2.5%
8
2.4%
16
2.5%
Chronic kidney disease (Count of Participants)
Count of Participants [Participants]
0
0%
0
0%
0
0%
0 Coexisting conditions (Count of Participants)
Count of Participants [Participants]
204
64.4%
227
69.2%
431
66.8%
1 Coexisting conditions (Count of Participants)
Count of Participants [Participants]
68
21.5%
56
17.1%
124
19.2%
2+ Coexisting conditions (Count of Participants)
Count of Participants [Participants]
45
14.2%
45
13.7%
90
14%

Outcome Measures

1. Primary Outcome
Title 14 Day Recovery Rate
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
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
Measure Participants 317 328
Count of Participants [Participants]
258
81.4%
117
35.7%
2. Secondary Outcome
Title 28 Day Recovery Rate
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

Outcome Measure Data

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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
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
Measure Participants 317 328
Count of Participants [Participants]
35
11%
162
49.4%
4. Secondary Outcome
Title Post-Randomization Time to Recover (Alive Hospital Discharge)
Description Number of day post-randomization required to achieve live hospital discharge.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
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
Measure Participants 317 328
Median (Inter-Quartile Range) [Days]
5
10

Adverse Events

Time Frame 28 Days
Adverse Event Reporting Description
Arm/Group Title Proxalutamide + Usual Care Placebo + Usual Care
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 (%) # Events Affected / at Risk (%) # Events
Total 35/317 (11%) 162/328 (49.4%)
Serious Adverse Events
Proxalutamide + Usual Care Placebo + Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 38/317 (12%) 170/328 (51.8%)
General disorders
Death 35/317 (11%) 162/328 (49.4%)
Respiratory, thoracic and mediastinal disorders
Mechanical Ventilation 5/317 (1.6%) 41/328 (12.5%)
Other (Not Including Serious) Adverse Events
Proxalutamide + Usual Care Placebo + Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 51/317 (16.1%) 11/328 (3.4%)
Gastrointestinal disorders
Diarrhea 51/317 (16.1%) 11/328 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. John McCoy
Organization Applied Biology, Inc.
Phone +1 (949)387-4526
Email johnm@appliedbiology.com
Responsible Party:
Applied Biology, Inc.
ClinicalTrials.gov Identifier:
NCT04728802
Other Study ID Numbers:
  • KP-DRUG-SARS-003
First Posted:
Jan 28, 2021
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021