Proxalutamide Treatment for Hospitalized COVID-19 Patients

June 22, 2021 updated by: Applied Biology, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

645

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Amazonas
      • Itacoatiara, Amazonas, Brazil
        • Hospital Regional José Mendes
      • Manacapuru, Amazonas, Brazil
        • Hospital de Campanha de Manacapuru
      • Manaus, Amazonas, Brazil
        • Hospital Oscar Nicolau
      • Manaus, Amazonas, Brazil
        • Hospital Prontocord
      • Manaus, Amazonas, Brazil
        • Hospital Samel
      • Manicore, Amazonas, Brazil
        • Hospital Regional Dr. Hamilton Maia Cidae
      • Maues, Amazonas, Brazil
        • Hospital Raimunda Francisca Dinelli da Silva
      • Parintins, Amazonas, Brazil
        • Hospital Regional Jofre Cohen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28
28 Day Mortality Rate
Time Frame: 28 days
All-cause mortality rate over 28 days post randomization.
28 days
Post-Randomization Time to Recover (Alive Hospital Discharge)
Time Frame: 28 days
Number of day post-randomization required to achieve live hospital discharge.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Biology, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-DRUG-SARS-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Yes, study data sets will be made available upon request after peer review and publication.

IPD Sharing Time Frame

Available upon request after peer review and publication.

IPD Sharing Access Criteria

Available upon request at data@appliedbiology.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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