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

NCT04870606 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GT0918-US-3001
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 8

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.

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (2)

• Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo

  In mITT (administrated at least one dose)，percentage of subjects who do not experience any of the following events due to all causes by Day 28: * Hospitalization for ≥ 24 hours, or * Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or * Death

  28 days

• Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo

  In mITT (treatment period \>7 days) , percentage of subjects who do not experience any of the following events due to all causes by Day 28: * Hospitalization for ≥ 24 hours, or * Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or * Death

  28 days

Secondary Outcomes (2)

• Proportion of Subjects With Hospitalization by Day 28

  28 days

• Viral Load

  at day 3,7,14,28

Study Arms (2)

GT0918+ standard of care

ACTIVE COMPARATOR

Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)

Drug: Proxalutamide (GT0918)

placebo+ standard of care

PLACEBO COMPARATOR

Placebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)

Drug: Placebo

Interventions

Proxalutamide (GT0918) DRUG

Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory

Also known as: standard of care

GT0918+ standard of care

Placebo DRUG

Placebo+Standard of care determined by PI and local regulatory

Also known as: standard of care

placebo+ standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Understand and agree to comply with planned study procedures.
• Male subjects with age ≥18 years of age at the time of randomization.
• Are currently not hospitalized.
• Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset
• 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.
• 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.

You may not qualify if:

• Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min
• Serum total bilirubin \> 1.5 x ULN (upper limit of normal) and AST and ALT \>3x ULN
• 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.
• 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 interventions.
• Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
• 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 \[HIV\]).
• Have any co-morbidity requiring surgery within \<7 days, or that is considered life-threatening within 30 days.
• Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (8)

Absolute Clinical Research

Phoenix, Arizona, 85051, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 29677, United States

Location

Olivo Medical and Wellness Center

Chicago, Illinois, 60618, United States

Location

Gtc Research

Shawnee Mission, Kansas, 66218, United States

Location

Platinum Research Network, LLC

Metairie, Louisiana, 70006, United States

Location

Main Street Physician's Care

Little River, South Carolina, 29566, United States

Location

Lotus Clinical Research

Houston, Texas, 77024, United States

Location

MeSH Terms

Interventions

proxalutamide; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Millie Gu
• Organization: Suzhou Kintor Pharmaceuticals,Inc.

PR@kintor.com.cn

+86- 512 6263 9938

Study Officials

• Wilson Lu

  Suzhou Kintor Pharmaceuticals,Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: March 5, 2021
• Primary Completion: January 24, 2022
• Study Completion: April 6, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)