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Trial record 1 of 1 for:    NCT04728802
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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. Identifier: NCT04728802
Recruitment Status : Active, not recruiting
First Posted : January 28, 2021
Last Update Posted : March 19, 2021
Information provided by (Responsible Party):
Applied Biology, Inc.

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
Covid19 SARS (Severe Acute Respiratory Syndrome) Drug: Proxalutamide Drug: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 590 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proxalutamide Treatment for Hospitalized COVID-19 Patients
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : March 22, 2021
Estimated Study Completion Date : April 22, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Proxalutamide + Standard of Care
Proxalutamide + standard of care as determined by the PI
Drug: Proxalutamide
Proxalutamide 300mg q.d

Placebo Comparator: Standard Care
Standard of care as determined by the PI
Drug: Standard of Care
Standard of care drugs as determined by the PI

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 or 5
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04728802

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Centro Clínico Advance, SGAS 915, Lote 69/70, Sala 262
Brasília, DF, Brazil, 70390-150
Sponsors and Collaborators
Applied Biology, Inc.
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Principal Investigator: Flavio Cadegiani, MD Applied Biology, Inc.
Study Director: Andy Goren, MD Applied Biology, Inc.
Additional Information:

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Responsible Party: Applied Biology, Inc. Identifier: NCT04728802    
Other Study ID Numbers: KP-DRUG-SARS-003
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Biology, Inc.:
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases