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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.

Tracking Information
First Submitted Date  ICMJE January 27, 2021
First Posted Date  ICMJE January 28, 2021
Results First Submitted Date  ICMJE June 15, 2021
Results First Posted Date  ICMJE June 23, 2021
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE February 1, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
14 Day Recovery Rate [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
Treatment efficacy of Proxalutamide relative to standard of care arm as assessed by the COVID-19 ordinal scale [ Time Frame: Day 14 ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • 28 Day Recovery Rate [ Time Frame: 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
  • 28 Day Mortality Rate [ Time Frame: 28 days ]
    All-cause mortality rate over 28 days post randomization.
  • Post-Randomization Time to Recover (Alive Hospital Discharge) [ Time Frame: 28 days ]
    Number of day post-randomization required to achieve live hospital discharge.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proxalutamide Treatment for Hospitalized COVID-19 Patients
Official Title  ICMJE Proxalutamide Treatment for Hospitalized COVID-19 Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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.
Masking: Double (Participant, Care Provider)
Masking Description:
Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE
  • Drug: Proxalutamide
    Proxalutamide 300mg q.d
  • Drug: Placebo
    Placebo pill
Study Arms  ICMJE
  • Active Comparator: Proxalutamide + Usual Care
    Proxalutamide + usual care as determined by care provider
    Intervention: Drug: Proxalutamide
  • Placebo Comparator: Placebo + Usual Care
    Placebo + usual care as determined by care provider
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2021)
645
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2021)
600
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  13. 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
  14. Subject likely to transfer to another hospital within the next 28 days
  15. Subject (or legally authorized representative) not willing or unable to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04728802
Other Study ID Numbers  ICMJE KP-DRUG-SARS-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Yes, study data sets will be made available upon request after peer review and publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Available upon request after peer review and publication.
Access Criteria: Available upon request at data@appliedbiology.com
Responsible Party Applied Biology, Inc.
Study Sponsor  ICMJE Applied Biology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Flavio Cadegiani, MD Applied Biology, Inc.
Study Director: Andy Goren, MD Applied Biology, Inc.
PRS Account Applied Biology, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP