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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04870606
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Kintor Pharmaceutical Inc,

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
Efficacy and Safety Drug: Proxalutamide (GT0918) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 668 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 : March 5, 2021
Estimated Primary Completion Date : January 24, 2022
Estimated Study Completion Date : May 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GT0918+ standard of care Drug: Proxalutamide (GT0918)
Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
Other Name: standard of care

Placebo Comparator: placebo+ standard of care Drug: Placebo
Placebo+Standard of care determined by PI and local regulatory
Other Name: standard of care




Primary Outcome Measures :
  1. Efficacy of Proxalutamide [ Time Frame: 28 days ]
    percentage of hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  8. 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:

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

  5. 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.
  6. Have known allergies to any of the components used in the formulation of the interventions.
  7. Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
  8. 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]).
  9. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.
  10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

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 ClinicalTrials.gov identifier (NCT number): NCT04870606


Contacts
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Contact: Clinical operation 86-512-62639909 kintor.co@kintor.com.cn

Locations
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United States, Arizona
Absolute Clinical Research Recruiting
Phoenix, Arizona, United States, 85051
United States, California
Long Beach Clinical Trials Recruiting
Long Beach, California, United States, 90806
United States, Georgia
WR-Mount Vernon Clinical Research, LLC Recruiting
Sandy Springs, Georgia, United States, 29677
United States, Illinois
Olivo Medical and Wellness Center Recruiting
Chicago, Illinois, United States, 60618
United States, Kansas
Gtc Research Recruiting
Shawnee Mission, Kansas, United States, 66218
United States, Louisiana
Platinum Research Network, LLC Recruiting
Metairie, Louisiana, United States, 70006
United States, South Carolina
Main Street Physician's Care Recruiting
Little River, South Carolina, United States, 29566
United States, Texas
Lotus Clinical Research Recruiting
Houston, Texas, United States, 77024
Sponsors and Collaborators
Suzhou Kintor Pharmaceutical Inc,
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Responsible Party: Suzhou Kintor Pharmaceutical Inc,
ClinicalTrials.gov Identifier: NCT04870606    
Other Study ID Numbers: GT0918-US-3001
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No