COVID-19Phase 3NCT04869228
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
A Phase 3 study of COVID-19, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- COVID-19
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Aug 2021to 2 Aug 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males age ≥18 years of age at the time of randomization
- Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
- The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization
- Subjects with adequate liver and renal function
- Agree to the collection of nasopharyngeal swabs and venous blood
- The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute
- 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
- Have known allergies to any of the components used in the formulation of the study drug or placebo
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo
- Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days
- Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose
Show all 9Show fewer
- Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening
- Are investigator site personnel directly affiliated with this study
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease
Read the detailed description
The subjects in the experimental group will receive GT0918 (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment. The subjects in the control group will receive placebo (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment.
- Conditions
- COVID-19
- Being tested
- GT0918 tablets or placebo
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT0918 tablets or placeboDrug
GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals
| Study group | Role | What they receive |
|---|---|---|
| GT0918 in the treatment arm | Experimental | GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals Receives: Drug: GT0918 tablets or placebo |
| Placebo in the placebo arm | Placebo comparator | placebo : oral, 1 time / day, 2 tablets / time, after meals Receives: Drug: GT0918 tablets or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects requiring oxygen by Day 28
Measured: 28days
Secondary outcomes (1)
Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
Measured: 28days
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 start4 Aug 2021
- Primary completion2 Sep 2022
- Study completion2 Aug 2023
Why it stopped: This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristhieni Rodrigues, Principal investigator, Hospital Santa Paula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869228
- Sponsor's protocol ID
- GT0918-MR-3001
- Status last verified
- Aug 2023
- First submitted
- 29 Apr 2021
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
- ClinicalTrials.gov ID
- NCT04869228
- Acronym / sponsor ID
- GT0918-MR-3001
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 3 May 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.
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease
Detailed description
The subjects in the experimental group will receive GT0918 (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment. The subjects in the control group will receive placebo (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GT0918 in the treatment arm | Experimental | Drug: GT0918 tablets or placeboGT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals |
| Placebo in the placebo arm | Placebo comparator | Drug: GT0918 tablets or placeboplacebo : oral, 1 time / day, 2 tablets / time, after meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult males age ≥18 years of age at the time of randomization
- Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
- The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization
- Subjects with adequate liver and renal function
- Agree to the collection of nasopharyngeal swabs and venous blood
Key exclusion criteria (9 listed)
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute
- 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
- Have known allergies to any of the components used in the formulation of the study drug or placebo
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo
- Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days
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 |
|---|---|---|
| GT0918 tablets or placeboGT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals | Drug | GT0918 in the treatment arm, Placebo in the placebo arm |
Primary outcome
Percentage of subjects requiring oxygen by Day 28
Time frame: 28days
1 secondary outcome
Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
Time frame: 28days
Results and safety
The study was stopped early (reason given: This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
Cristhieni Rodrigues principal investigator
Hospital Santa Paula
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of COVID-19, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in Brazil.
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 6 inclusion and 9 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 1 site in Brazil. 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: This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.). 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?
Percentage of subjects requiring oxygen by Day 28 (time frame: 28days). 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; AzTrials last refreshed its copy on 29 Oct 2026.