Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

• ClinicalTrials.gov Identifier: NCT04870606
• Recruitment Status: Completed
• First Posted: May 3, 2021
• Last Update Posted: June 22, 2022
• Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Information provided by (Responsible Party): Suzhou Kintor Pharmaceutical Inc,

Study Description

Brief Summary:

The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.

Condition or disease	Intervention/treatment	Phase
Efficacy and Safety	Drug: Proxalutamide (GT0918); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 733 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness
• Actual Study Start Date: March 5, 2021
• Actual Primary Completion Date: January 24, 2022
• Actual Study Completion Date: April 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: GT0918+ standard of care	Drug: Proxalutamide (GT0918); Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory; Other Name: standard of care
Placebo Comparator: placebo+ standard of care	Drug: Placebo; Placebo+Standard of care determined by PI and local regulatory; Other Name: standard of care

Outcome Measures

Primary Outcome Measures :

1. Efficacy of Proxalutamide [ Time Frame: 28 days ]
   percentage of hospitalization

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2. Understand and agree to comply with planned study procedures.
3. Male subjects with age ≥18 years of age at the time of randomization.
4. Are currently not hospitalized.
5. Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset
6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose.

7. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose.

   Use an acceptable method of contraception such as:

   • Highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to

     • combination oral contraceptives
     • implanted contraceptives, or
     • intrauterine devices.

   • Effective methods of contraception comprise but are not limited to

     • diaphragms with spermicide or cervical sponges.
     • men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide.
8. Agree to the collection of nasopharyngeal swabs and venous blood.

Exclusion Criteria:

1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
2. Estimated glomerular filtration rate (eGFR) < 30 ml/min
3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN

4. Subjects with significant cardiovascular disease as following:

   i. heart failure NYHA class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long QT syndrome.

5. 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.
6. Have known allergies to any of the components used in the formulation of the interventions.
7. Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]).
9. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.
10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

Contacts and Locations

Locations

United States, Arizona

Absolute Clinical Research

Phoenix, Arizona, United States, 85051

United States, California

Long Beach Clinical Trials

Long Beach, California, United States, 90806

United States, Georgia

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States, 29677

United States, Illinois

Olivo Medical and Wellness Center

Chicago, Illinois, United States, 60618

United States, Kansas

Gtc Research

Shawnee Mission, Kansas, United States, 66218

United States, Louisiana

Platinum Research Network, LLC

Metairie, Louisiana, United States, 70006

United States, South Carolina

Main Street Physician's Care

Little River, South Carolina, United States, 29566

United States, Texas

Lotus Clinical Research

Houston, Texas, United States, 77024

Sponsors and Collaborators

Suzhou Kintor Pharmaceutical Inc,

More Information

• Responsible Party: Suzhou Kintor Pharmaceutical Inc,
• ClinicalTrials.gov Identifier: NCT04870606
• Other Study ID Numbers: GT0918-US-3001
• First Posted: May 3, 2021
• Last Update Posted: June 22, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No