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A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

NCT05009732 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-08-18

No results posted yet for this study

Summary

This study is an adaptive Phase III randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted globally. The study will compare GT0918 plus standard of care (SOC) with the placebo plus SOC. Approximately 762 subjects will be randomized in a 1:1 ratio to either GT0918 plus SOC or placebo plus SOC group.

Conditions

  • Covid19

Interventions

DRUG

GT0918

300mg once daily orally

DRUG

Standard of care

Local standard of care per written policies or guidelines

DRUG

Matching placebo

Matching placebo

Sponsors & Collaborators

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-02-06
Completion
2023-07-14
FDA Drug
Yes

Countries

  • United States
  • China
  • Philippines
  • South Africa
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009732 on ClinicalTrials.gov