Covid19Phase 3NCT05009732
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
A Phase 3 study testing GT0918 in people with Covid19, run by Suzhou Kintor Pharmaceutical Inc, at 30 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- GT0918
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 30 sitesin 5 countries
- Study dates
- 30 Sep 2021to 14 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States8 sites
Raymond G. Murphy VA Medical Center
Albuquerque, New Mexico, 87108
Medical City Fort Worth
Fort Worth, Texas, 76104
Hannibal Clinic (HC)
Hannibal, Missouri, 63401
Alternative Research Associates LLC.
Hialeah, Florida, 33012
Sparrow Hospital
Lansing, Michigan, 48912
PRX Research
Mesquite, Texas, 75149
Saint Lawrence Health System
New York, New York, 13676
Ascension St. John Medical Center
Tulsa, Oklahoma, 74104
Ukraine7 sites
Communal Noncommercial Profit
Dnipro, Dnipro Oblast, 49051
Ivano-Frankivsk Clinical Regional Infectious Diseases Hospital
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007
Kharkiv city clinical hospital #13
Kharkiv, Kharkiv Oblast, 61035
CNE of Kharkov RC Reg Cl Infectious Hospital
Kharkiv, Kharkiv Oblast, 61096
City Clinical infectious Hospital
Odesa, Odesa Oblast, 65026
Poltava Regional Clinical
Poltava, Poltava Oblast, 36000
CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases
Vinnytsia, Vinnytsia Oblast, 21029
Philippines6 sites
Davao Doctors Hospital
Davao City, Davao Region, 8000
St. Paul's Hospital
Iloilo City, Iloilo, 5000
Philippine General Hospital
Malina, Metro Malina, 1000
Mary Johnston Hospital (MJH)
Manila, National Capital Region, 1012
Quirino Memorial Medical Center
Quezon City, National Capital Region, 1109
Lung Center of the Philippines
Quezon City, 1100
South Africa6 sites
Johese Clinical Research: Unitas
Centurion, 0157
Drs Sarvan and Moodley
Durban, 4320
TASK Eden
George, 6529
Johese Clinical Research ZAH
Pretoria, 0002
Dr JM Engelbrecht Practice, Vergelegen Mediclinic
Somerset, 7130
Clinical Projects Research
Worcester, 6850
China3 sites
Beijing Ditan Hospital Capital Medical University
Beijing, 100015
Shanghai Public Health Clinical Center
Jinshan, Shanghai Municipality, 201052
The Third People's Hospital of Shenzhen
Longgang District, Shenzhen, 518112
About this study
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
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.
Read the 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
- Conditions
- Covid19
- Being tested
- GT0918, Standard of care, Matching placebo
- Keywords
- SARS-CoV-2, Covid
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT0918Drug
Also called Proxalutamide
300mg once daily orally
Standard of careDrug
Also called SoC
Local standard of care per written policies or guidelines
Matching placeboDrug
Also called Placebo
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Standard of care; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days from enrollment
Secondary outcomes (1)
60-day mortality
All cause mortality at 60 days after enrollment
Measured: 60 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 Sep 2021
- Primary completion6 Feb 2023
- Study completion14 Jul 2023
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009732
- Sponsor's protocol ID
- GT0918-US-3002
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2021
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05009732
- Acronym / sponsor ID
- GT0918-US-3002
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Covid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proxalutamide (GT0918) plus standard of care | Experimental | Drug: GT0918, Drug: Standard of careParticipants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion |
| Placebo plus standard of care | Placebo comparator | Drug: Standard of care, Drug: Matching placeboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (18 listed)
- 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:
- Neutropenia (absolute neutrophil count <1000 cells/μL) (<1.0 x 10^3/μL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT0918Also: Proxalutamide300mg once daily orally | Drug | Proxalutamide (GT0918) plus standard of care |
| Standard of careAlso: SoCLocal standard of care per written policies or guidelines | Drug | Placebo plus standard of care, Proxalutamide (GT0918) plus standard of care |
| Matching placeboAlso: PlaceboMatching placebo | Drug | Placebo plus standard of care |
Primary outcome
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.
1 secondary outcome
60-day mortality
Time frame: 60 days from enrollment
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GT0918 in people with Covid19, run by Suzhou Kintor Pharmaceutical Inc, at 30 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Ukraine, Philippines, South Africa, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to Clinical deterioration is evaluated by Day 30. (time frame: 30 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.