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

• Sponsor: Suzhou Kintor Pharmaceutical Inc, (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04869228
• Collaborator: (none)
• Enrollment: 724
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 73.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: GT0918 tablets or placebo	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 724 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 4, 2021
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of subjects requiring oxygen by Day 28 [28days]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Santa Paula	São Paulo	SP	Brazil	04556-100

Sponsors and Collaborators

• Suzhou Kintor Pharmaceutical Inc,

Investigators

• Principal Investigator: Cristhieni Rodrigues, Hospital Santa Paula

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzhou Kintor Pharmaceutical Inc,
• ClinicalTrials.gov Identifier: NCT04869228
• Other Study ID Numbers: GT0918-MR-3001
• First Posted: May 3, 2021
• Last Update Posted: Oct 19, 2021
• Last Verified: Jul 1, 2021

• 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
• Keywords provided by Suzhou Kintor Pharmaceutical Inc,: COVID-19
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 19, 2021