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

NCT05009732 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: GT0918-US-3002
• Study Type: interventional
• Target: 139
• Locations: 5 countries
• Sites: 30

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.

Conditions

Covid19

Keywords

SARS-CoV-2; Covid

Outcome Measures

Primary Outcomes (1)

• The time to Clinical deterioration is evaluated by Day 30.

  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.

  30 days from enrollment

Secondary Outcomes (1)

• 60-day mortality

  60 days from enrollment

Study Arms (2)

Proxalutamide (GT0918) plus standard of care

EXPERIMENTAL

Participants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion

Drug: GT0918; Drug: Standard of care

Placebo plus standard of care

PLACEBO COMPARATOR

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

Drug: Standard of care; Drug: Matching placebo

Interventions

GT0918 DRUG

300mg once daily orally

Also known as: Proxalutamide

Proxalutamide (GT0918) plus standard of care

Standard of care DRUG

Local standard of care per written policies or guidelines

Also known as: SoC

Placebo plus standard of care; Proxalutamide (GT0918) plus standard of care

Matching placebo DRUG

Matching placebo

Also known as: Placebo

Placebo plus 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:

• 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-19.
• 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
• PaO2/FiO≤300mmHg 1mmHg=0.133kPa
• Resting state SpO2 ≤ 93% on room air
• All women of childbearing potential defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Highly effective contraception methods include:
• Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or
• Use of one of the following combinations (a+b or a+c or b+c):

You may not qualify if:

• 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.
• Allergy to any study medication.
• Received monoclonal antibody, convalescent plasma, or intravenous immunoglobulin \[IVIg\]) for COVID-19 withing 14 days of screening.
• Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
• Have a history of VTE (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 12 weeks prior to screening or have a history of recurrent (\>1) VTE (DVT/PE).
• Subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing.

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (30)

Alternative Research Associates LLC.

Hialeah, Florida, 33012, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Hannibal Clinic (HC)

Hannibal, Missouri, 63401, United States

Location

Raymond G. Murphy VA Medical Center

Albuquerque, New Mexico, 87108, United States

Location

Saint Lawrence Health System

New York, New York, 13676, United States

Location

Ascension St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

PRX Research

Mesquite, Texas, 75149, United States

Location

Shanghai Public Health Clinical Center

Zhujing, Shanghai Municipality, 201052, China

Location

The Third People's Hospital of Shenzhen

Longgang District, Shenzhen, 518112, China

Location

Beijing Ditan Hospital Capital Medical University

Beijing, 100015, China

Location

Davao Doctors Hospital

Davao City, Davao Region, 8000, Philippines

Location

St. Paul's Hospital

Iloilo City, Iloilo, 5000, Philippines

Location

Philippine General Hospital

Malina, Metro Malina, 1000, Philippines

Location

Mary Johnston Hospital (MJH)

Manila, National Capital Region, 1012, Philippines

Location

Quirino Memorial Medical Center

Quezon City, National Capital Region, 1109, Philippines

Location

Lung Center of the Philippines

Quezon City, 1100, Philippines

Location

Johese Clinical Research: Unitas

Centurion, 0157, South Africa

Location

Drs Sarvan and Moodley

Durban, 4320, South Africa

Location

TASK Eden

George, 6529, South Africa

Location

Johese Clinical Research ZAH

Pretoria, 0002, South Africa

Location

Dr JM Engelbrecht Practice, Vergelegen Mediclinic

Somerset, 7130, South Africa

Location

Clinical Projects Research

Worcester, 6850, South Africa

Location

Communal Noncommercial Profit

Dnipro, Dnipro Oblast, 49051, Ukraine

Location

Ivano-Frankivsk Clinical Regional Infectious Diseases Hospital

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007, Ukraine

Location

Kharkiv city clinical hospital #13

Kharkiv, Kharkivs’ka Oblast’, 61035, Ukraine

Location

CNE of Kharkov RC Reg Cl Infectious Hospital

Kharkiv, Kharkivs’ka Oblast’, 61096, Ukraine

Location

City Clinical infectious Hospital

Odesa, Odesa Oblast, 65026, Ukraine

Location

Poltava Regional Clinical

Poltava, Poltava Oblast, 36000, Ukraine

Location

CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

proxalutamide; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: September 30, 2021
• Primary Completion: February 6, 2023
• Study Completion: July 14, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); ZA (6); UA (7); PH (6); CN (3)