Efficacy and SafetyPhase 3NCT04870606
Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness
A Phase 3 study testing Proxalutamide (GT0918) in people with Efficacy and Safety, run by Suzhou Kintor Pharmaceutical Inc, at 8 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Proxalutamide (GT0918)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 733 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Mar 2021to 6 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Understand and agree to comply with planned study procedures.
- Male subjects with age ≥18 years of age at the time of randomization.
- Are currently not hospitalized.
- Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset
- Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose.
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- 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.
- Use an acceptable method of contraception such as:
- Highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to
- combination oral contraceptives
- implanted contraceptives, or
- intrauterine devices.
- Effective methods of contraception comprise but are not limited to
- diaphragms with spermicide or cervical sponges.
- men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide.
- Agree to the collection of nasopharyngeal swabs and venous blood.
Who cannot join
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
- Estimated glomerular filtration rate (eGFR) < 30 ml/min
- Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN
- 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.
- Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen.
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- Have known allergies to any of the components used in the formulation of the interventions.
- Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]).
- Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.
- Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Olivo Medical and Wellness Center
Chicago, Illinois, 60618
Lotus Clinical Research
Houston, Texas, 77024
Main Street Physician's Care
Little River, South Carolina, 29566
Long Beach Clinical Trials
Long Beach, California, 90806
Platinum Research Network, LLC
Metairie, Louisiana, 70006
Absolute Clinical Research
Phoenix, Arizona, 85051
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 29677
Gtc Research
Shawnee Mission, Kansas, 66218
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.
Read the detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be conducted in around 100 sites in the USA and other countries. This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for futility, efficacy, or safety. The study population will be subjects with mild to moderate COVID-19 illness chosen to evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can effectively prevent progression to the severe form of COVID-19 illness. Randomization is essential for establishing efficacy of these new therapeutic agents.
The blood samples for PK analysis need to be collected for at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group with 1:1 ratio.
- Conditions
- Efficacy and Safety
- Being tested
- Proxalutamide (GT0918), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proxalutamide (GT0918)Drug
Also called standard of care
Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
PlaceboDrug
Also called standard of care
Placebo+Standard of care determined by PI and local regulatory
| Study group | Role | What they receive |
|---|---|---|
| GT0918+ standard of care | Active comparator | Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334) Receives: Drug: Proxalutamide (GT0918) |
| placebo+ standard of care | Placebo comparator | Placebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
In mITT (administrated at least one dose)，percentage of subjects who do not experience any of the following events due to all causes by Day 28:
- Hospitalization for ≥ 24 hours, or
- Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or
- Death
Measured: 28 days
Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
In mITT (treatment period >7 days) , percentage of subjects who do not experience any of the following events due to all causes by Day 28:
- Hospitalization for ≥ 24 hours, or
- Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or
- Death
Measured: 28 days
Secondary outcomes (2)
Proportion of Subjects With Hospitalization by Day 28
Percentage of subjects who do experience any of the following events due to all causes by Day 28:
- Hospitalization for ≥ 24 hours, or
- Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or
- Death
Measured: 28 days
Viral Load
Changes from baseline in SARS-CoV-2 viral load at days 3, 7, 14, and 28.
Measured: at day 3,7,14,28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start5 Mar 2021
- Primary completion24 Jan 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Efficacy and SafetyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilson Lu, Study director, Suzhou Kintor Pharmaceuticals,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870606
- Sponsor's protocol ID
- GT0918-US-3001
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2021
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness
- ClinicalTrials.gov ID
- NCT04870606
- Acronym / sponsor ID
- GT0918-US-3001
- Conditions
- Efficacy and Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be conducted in around 100 sites in the USA and other countries. This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for futility, efficacy, or safety. The study population will be subjects with mild to moderate COVID-19 illness chosen to evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can effectively prevent progression to the severe form of COVID-19 illness. Randomization is essential for establishing efficacy of these new therapeutic agents.
The blood samples for PK analysis need to be collected for at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group with 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GT0918+ standard of care | Active comparator | Drug: Proxalutamide (GT0918)Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334) |
| placebo+ standard of care | Placebo comparator | Drug: PlaceboPlacebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Understand and agree to comply with planned study procedures.
- Male subjects with age ≥18 years of age at the time of randomization.
- Are currently not hospitalized.
- Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days of onset of symptoms onset
Key exclusion criteria (11 listed)
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
- Estimated glomerular filtration rate (eGFR) < 30 ml/min
- Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN
- Subjects with significant cardiovascular disease as following:
- Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen.
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 |
|---|---|---|
| Proxalutamide (GT0918)Also: standard of careProxalutamide (GT0918)+Standard of care determined by PI and local regulatory | Drug | GT0918+ standard of care |
| PlaceboAlso: standard of carePlacebo+Standard of care determined by PI and local regulatory | Drug | placebo+ standard of care |
Primary outcome
Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
Time frame: 28 days
In mITT (administrated at least one dose)，percentage of subjects who do not experience any of the following events due to all causes by Day 28: * Hospitalization for ≥ 24 hours, or * Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or * Death
Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
Time frame: 28 days
In mITT (treatment period >7 days) , percentage of subjects who do not experience any of the following events due to all causes by Day 28: * Hospitalization for ≥ 24 hours, or * Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%, or * Death
2 secondary outcomes
Proportion of Subjects With Hospitalization by Day 28
Time frame: 28 days
Viral Load
Time frame: at day 3,7,14,28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Wilson Lu study director
Suzhou Kintor Pharmaceuticals,Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proxalutamide (GT0918) in people with Efficacy and Safety, run by Suzhou Kintor Pharmaceutical Inc, at 8 sites in United States.
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 16 inclusion and 11 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: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo (time frame: 28 days). The study lists 2 primary outcomes in all. 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 2 Jan 2024.