A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
Overview
- Phase
- Phase 3
- Intervention
- Standard of care
- Conditions
- Covid19
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Enrollment
- 139
- Locations
- 30
- Primary Endpoint
- The time to Clinical deterioration is evaluated by Day 30.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
Coronavirus disease 2019 (COVID-19) emerged in late 2019 and spread rapidly, resulting in a global pandemic.SARS-CoV-2 encodes nonstructural and structural proteins required for its viral life cycle. Among them, the spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by recognizing and attaching to ACE2 transmembrane protein on host cells. Kintor protocol has been designed to evaluate efficacy and safety of GT0918 in hospitalized subjects with COVID-19 illness. The target population of this study are hospitalized subjects with COVID-19 illness with positive SARS-CoV-2 virus test within 72 hours of randomization. The study will evaluate anti-androgen therapy may effectively prevent progression to the more severe form of COVID-19 illness and death, shorten the time to sustained recovery and decrease the mortality rate. Subject will receive either GT0918 plus standard of care or matched placebo plus standard of care. GT0918/placebo will be given 300mg orally once a day around 30 minutes after meal for 7 days and can be extended up to 14 days per investigator discretion
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- •Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- •Male and non-pregnant female subjects with age ≥18 years of age at the time of randomization.
- •Admitted to a hospital with symptoms suggestive of severe COVID-
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (including rapid antigen test) in any specimen, as documented by either of the following:
- •PCR positive in sample collected \< 72 hours prior to randomization; OR
- •PCR positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \> 24 hours, etc) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •Illness of any duration, and at least one of the following:
- •Shortness of breath, RR≥30 /minute
- •Clinical signs indicative of progressive aggravation, lung radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) showing \>50% progression within 24-48 hours
Exclusion Criteria
- •Subjects are excluded from the study if any of the following criteria apply:
- •ALT/AST \> 3 times the upper limit of normal.
- •Serum total bilirubin \> 1.5 x ULN (upper limit of normal)
- •Estimated glomerular filtration rate (eGFR) \< 30 ml/min (including patients receiving hemodialysis or hemofiltration).
- •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.
- •Neutropenia (absolute neutrophil count \<1000 cells/μL) (\<1.0 x 10\^3/μL).
- •Lymphopenia (absolute lymphocyte count \<200 cells/μL) (\<0.20 x 10\^3/μL)
- •Pregnancy or breast feeding
- •Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
Arms & Interventions
Proxalutamide (GT0918) plus standard of care
Participants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Intervention: Standard of care
Proxalutamide (GT0918) plus standard of care
Participants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Intervention: GT0918
Placebo plus standard of care
Participants will receive placebo tablets matching Proxalutamide (GT0918) orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Intervention: Standard of care
Placebo plus standard of care
Participants will receive placebo tablets matching Proxalutamide (GT0918) orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Intervention: Matching placebo
Outcomes
Primary Outcomes
The time to Clinical deterioration is evaluated by Day 30.
Time Frame: 30 days from enrollment
Clinical deterioration is defined as the need for intensive care unit level care (ICU) or invasive mechanical ventilation/ECMO or all-cause mortality by Day 30.
Secondary Outcomes
- 60-day mortality(60 days from enrollment)