A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
GT0918 tablets or placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
- Adult males age ≥18 years of age at the time of randomization
- Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
- The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization
- Subjects with adequate liver and renal function
- Agree to the collection of nasopharyngeal swabs and venous blood
- The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria:
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute
- 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
- Have known allergies to any of the components used in the formulation of the study drug or placebo
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo
- Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days
- Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose
- Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening
- Are investigator site personnel directly affiliated with this study
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization
Sites / Locations
- Hospital Santa Paula
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GT0918 in the treatment arm
Placebo in the placebo arm
Arm Description
GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals
placebo : oral, 1 time / day, 2 tablets / time, after meals
Outcomes
Primary Outcome Measures
Percentage of subjects requiring oxygen by Day 28
Secondary Outcome Measures
Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
Full Information
NCT ID
NCT04869228
First Posted
April 29, 2021
Last Updated
August 14, 2023
Sponsor
Suzhou Kintor Pharmaceutical Inc,
1. Study Identification
Unique Protocol Identification Number
NCT04869228
Brief Title
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
Official Title
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Kintor Pharmaceutical Inc,
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease
Detailed Description
The subjects in the experimental group will receive GT0918 (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment. The subjects in the control group will receive placebo (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GT0918 in the treatment arm
Arm Type
Experimental
Arm Description
GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals
Arm Title
Placebo in the placebo arm
Arm Type
Placebo Comparator
Arm Description
placebo : oral, 1 time / day, 2 tablets / time, after meals
Intervention Type
Drug
Intervention Name(s)
GT0918 tablets or placebo
Intervention Description
GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals
Primary Outcome Measure Information:
Title
Percentage of subjects requiring oxygen by Day 28
Time Frame
28days
Secondary Outcome Measure Information:
Title
Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
Time Frame
28days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males age ≥18 years of age at the time of randomization
Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization
Subjects with adequate liver and renal function
Agree to the collection of nasopharyngeal swabs and venous blood
The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria:
Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute
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
Have known allergies to any of the components used in the formulation of the study drug or placebo
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo
Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days
Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose
Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening
Are investigator site personnel directly affiliated with this study
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristhieni Rodrigues
Organizational Affiliation
Hospital Santa Paula
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Paula
City
São Paulo
State/Province
SP
ZIP/Postal Code
04556-100
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
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