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

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

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: GT0918 tablets or placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04556-100
      • Hospital Santa Paula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT0918 in the treatment arm; GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals	Drug: GT0918 tablets or placebo; GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals
Placebo Comparator: Placebo in the placebo arm; placebo : oral, 1 time / day, 2 tablets / time, after meals	Drug: GT0918 tablets or placebo; GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects requiring oxygen by Day 28	28days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Investigators: Principal Investigator: Cristhieni Rodrigues, Hospital Santa Paula

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GT0918-MR-3001

Drug and device information, study documents

• 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