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
Phase 3
Terminated
- Conditions
- COVID-19
- Interventions
- Drug: GT0918 tablets or placebo
- Registration Number
- NCT04869228
- Lead Sponsor
- Suzhou Kintor Pharmaceutical Inc,
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 380
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GT0918 in the treatment arm GT0918 tablets or placebo GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals Placebo in the placebo arm GT0918 tablets or placebo placebo : oral, 1 time / day, 2 tablets / time, after meals
- Primary Outcome Measures
Name Time Method Percentage of subjects requiring oxygen by Day 28 28days
- Secondary Outcome Measures
Name Time Method 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) 28days
Trial Locations
- Locations (1)
Hospital Santa Paula
🇧🇷São Paulo, SP, Brazil