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Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

Sponsor
Suzhou Kintor Pharmaceutical Inc, (Industry)
Overall Status
Completed
CT.gov ID
NCT04870606
Collaborator
(none)
733
Enrollment
8
Locations
2
Arms
12.9
Actual Duration (Months)
91.6
Patients Per Site
7.1
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 (GT0918) as a treatment for outpatients COVID-19 subjects.

Condition or Disease Intervention/Treatment Phase
  • Drug: Proxalutamide (GT0918)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
733 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness
Actual Study Start Date :
Mar 5, 2021
Actual Primary Completion Date :
Jan 24, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GT0918+ standard of care

Drug: Proxalutamide (GT0918)
Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
Other Names:
  • standard of care

    		•
    Placebo Comparator: placebo+ standard of care

    Drug: Placebo
    Placebo+Standard of care determined by PI and local regulatory
    Other Names:
  • standard of care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of Proxalutamide [28 days]

      percentage of hospitalization

    Eligibility Criteria

    Criteria

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

    1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

    2. Understand and agree to comply with planned study procedures.

    3. Male subjects with age ≥18 years of age at the time of randomization.

    4. Are currently not hospitalized.

    5. Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset

    6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose.

    7. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose.

    Use an acceptable method of contraception such as:

    • Highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to

    • combination oral contraceptives

    • implanted contraceptives, or

    • intrauterine devices.

    • Effective methods of contraception comprise but are not limited to

    • diaphragms with spermicide or cervical sponges.

    • men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide.

    1. Agree to the collection of nasopharyngeal swabs and venous blood.
    Exclusion Criteria:

    1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute

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

    3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN

    4. Subjects with significant cardiovascular disease as following:

    1. heart failure NYHA class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long QT syndrome.

    1. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen.

    2. Have known allergies to any of the components used in the formulation of the interventions.

    3. Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.

    4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]).

    5. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.

    6. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Absolute Clinical Research Phoenix Arizona United States 85051
    2 Long Beach Clinical Trials Long Beach California United States 90806
    3 WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia United States 29677
    4 Olivo Medical and Wellness Center Chicago Illinois United States 60618
    5 Gtc Research Shawnee Mission Kansas United States 66218
    6 Platinum Research Network, LLC Metairie Louisiana United States 70006
    7 Main Street Physician's Care Little River South Carolina United States 29566
    8 Lotus Clinical Research Houston Texas United States 77024

    Sponsors and Collaborators

    • Suzhou Kintor Pharmaceutical Inc,

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzhou Kintor Pharmaceutical Inc,
    ClinicalTrials.gov Identifier:
    NCT04870606
    Other Study ID Numbers:
    • GT0918-US-3001
    First Posted:
    May 3, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 22, 2022