Clinical trial NCT04869228: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 380
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adult males age ≥18 years of age at the time of randomization
2. 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)
3. 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
4. Subjects with adequate liver and renal function
5. Agree to the collection of nasopharyngeal swabs and venous blood
6. 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:

1. 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
2. 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
3. Have known allergies to any of the components used in the formulation of the study drug or placebo
4. 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
5. Have any co-morbidity anticipated to require surgery within \<7 days, or that is considered life threatening within 30 days
6. Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose
7. 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
8. Are investigator site personnel directly affiliated with this study
9. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization

Primary outcomes:
measure: Percentage of subjects requiring oxygen by Day 28
timeFrame: 28days
Secondary outcomes:
measure: 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)
timeFrame: 28days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Santa Paula
state: SP
Study officials:
affiliation: Hospital Santa Paula
name: Cristhieni Rodrigues
role: PRINCIPAL_INVESTIGATOR
References: