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

Sponsor

Suzhou Kintor Pharmaceutical Inc, (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05009732

Collaborator

(none)

762

Enrollment

Locations

Arms

Anticipated Duration (Months)

20.1

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: GT0918 Drug: Standard of care Drug: Matching placebo	Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

762 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: GT0918 300mg once daily orally Other Names: Proxalutamide Drug: Standard of care Local standard of care per written policies or guidelines Other Names: SoC
Placebo Comparator: 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	Drug: Standard of care Local standard of care per written policies or guidelines Other Names: SoC Drug: Matching placebo Matching placebo Other Names: Placebo

Arm

Intervention/Treatment

Experimental: 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

Drug: GT0918

300mg once daily orally

Other Names:

Proxalutamide

Drug: Standard of care

Local standard of care per written policies or guidelines

Other Names:

SoC

Placebo Comparator: 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

Drug: Standard of care

Local standard of care per written policies or guidelines

Other Names:

SoC

Drug: Matching placebo

Matching placebo

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

The time to Clinical deterioration is evaluated by Day 30. [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 Outcome Measures

60-day mortality [60 days from enrollment]
All cause mortality at 60 days after enrollment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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-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):

Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;

Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;
Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject;
In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of childbearing potential;

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. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Agree not to participate in another clinical trial for the treatment of COVID-19 through Day 60 after first dose.

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:

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.
Have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
Subjects with active myopathy
Is admitted to Intensive Care Units at randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alternative Research Associates LLC.	Hialeah	Florida	United States	33012
2	Sparrow Hospital	Lansing	Michigan	United States	48912
3	Hannibal Clinic (HC)	Hannibal	Missouri	United States	63401
4	Mercury Street Medical Group, PLLC	Butte	Montana	United States	56701
5	South Jersey Infectious	Somers Point	New Jersey	United States	08224
6	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
7	Raymond G. Murphy VA Medical Center	Albuquerque	New Mexico	United States	87108
8	Saint Lawrence Health System	New York	New York	United States	13676
9	Mercy Health St. Vincent Medical Center	Toledo	Ohio	United States	43608
10	Ascension St. John Medical Center	Tulsa	Oklahoma	United States	74104
11	AnMed Health Oglesby Center	Anderson	South Carolina	United States	29621
12	University of South Carolina	Columbia	South Carolina	United States	29203
13	Medical City Fort Worth	Fort Worth	Texas	United States	76104
14	Christus Good Shepherd Medical Center	Longview	Texas	United States	75601
15	PRX Research	Mesquite	Texas	United States	75149
16	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington	United States	98801
17	Shanghai Public Health Clinical Center	Jinshan	Shanghai	China	201052
18	The Third People's Hospital of Shenzhen	Longgang	Shenzhen	China	518112
19	Beijing Ditan Hospital Capital Medical University	Beijing		China	100015
20	Davao Doctors Hospital	Davao City	Davao	Philippines	8000
21	St. Paul's Hospital	Iloilo City	Iloilo	Philippines	5000
22	Philippine General Hospital	Malina	Metro Malina	Philippines	1000
23	Mary Johnston Hospital (MJH)	Manila	Metro Manila	Philippines	1012
24	Quirino Memorial Medical Center	Quezon City	Metro Manila	Philippines	1109
25	Lung Center of the Philippines	Quezon City		Philippines	1100
26	Johese Clinical Research: Unitas	Centurion		South Africa	0157
27	Drs Sarvan and Moodley	Durban		South Africa	4320
28	TASK Eden	George		South Africa	6529
29	Johese Clinical Research ZAH	Pretoria		South Africa	0002
30	Dr JM Engelbrecht Practice, Vergelegen Mediclinic	Somerset		South Africa	7130
31	Clinical Projects Research	Worcester		South Africa	6850
32	Communal Noncommercial Profit	Dnipro	Dnipro Oblast	Ukraine	49051
33	Ivano-Frankivsk Clinical Regional Infectious Diseases Hospital	Ivano-Frankivsk	Ivano-Frankivsk Oblast	Ukraine	76007
34	Kharkiv city clinical hospital #13	Kharkiv	Kharkiv Oblast	Ukraine	61035
35	CNE of Kharkov RC Reg Cl Infectious Hospital	Kharkiv	Kharkiv Oblast	Ukraine	61096
36	City Clinical infectious Hospital	Odesa	Odesa Oblast	Ukraine	65026
37	Poltava Regional Clinical	Poltava	Poltava Oblast	Ukraine	36000
38	CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases	Vinnytsia	Vinnytsia Oblast	Ukraine	21029

Sponsors and Collaborators

Suzhou Kintor Pharmaceutical Inc,

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzhou Kintor Pharmaceutical Inc,

ClinicalTrials.gov Identifier:

NCT05009732

Other Study ID Numbers:

GT0918-US-3002

First Posted:

Aug 17, 2021

Last Update Posted:

Jun 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suzhou Kintor Pharmaceutical Inc,

SARS-CoV-2

Covid

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 21, 2022