CompletedNCT04870606Updated Jan 2, 2024Results posted

Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

A Phase 3 interventional study of Proxalutamide (GT0918) and Placebo in Efficacy and Safety, sponsored by Suzhou Kintor Pharmaceutical Inc,. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-02.

Sponsored by Suzhou Kintor Pharmaceutical Inc, · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 733
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Efficacy and Safety

In context

Lead sponsor

Suzhou Kintor Pharmaceutical Inc, is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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:
i. 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.
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 733 participants (actual)

Study arms

Active comparator
GT0918+ standard of care
Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)
Drug: Proxalutamide (GT0918)
Placebo comparator
placebo+ standard of care
Placebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)
Drug: Placebo

Interventions

DrugProxalutamide (GT0918)
Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
Also known as: standard of care
DrugPlacebo
Placebo+Standard of care determined by PI and local regulatory
Also known as: standard of care

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 28 days

Secondary outcomes

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
Time frame: 28 days
Viral Load
Changes from baseline in SARS-CoV-2 viral load at days 3, 7, 14, and 28.
Time frame: at day 3,7,14,28

Results

Posted Jan 2, 2024

Participant flow

A total of 865 subjects were screened, of whom 132 subjects failed at screening. A total of 733 subjects were randomized in this study

Participant flow — Overall Study
Milestone	GT0918+ Standard of Care	Placebo+ Standard of Care
Started	366	367
Received at least one dose of treatment after randomised	365	365
Completed	354	359
Not completed	12	8

Outcome measures

PrimaryEfficacy 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

Time frame:: 28 days
Reported as:: Count of participants · Participants

Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
Participants	GT0918+ Standard of Care	Placebo+ Standard of Care
Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo	361	357

PrimarySensitivity 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

Time frame:: 28 days
Reported as:: Count of participants · Participants

Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo
Participants	GT0918+ Standard of Care	Placebo+ Standard of Care
Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo	348	339

Statistical analysis

GT0918+ Standard of Care vs Placebo+ Standard of Care · Cochran-Mantel-Haenszel · p = 0.0181 · Mean difference (final values): 0.025

SecondaryProportion 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

Time frame:: 28 days
Reported as:: Count of participants · Participants

Proportion of Subjects With Hospitalization by Day 28
Participants	GT0918+ Standard of Care	Placebo+ Standard of Care
Proportion of Subjects With Hospitalization by Day 28	4	8

Statistical analysis

GT0918+ Standard of Care vs Placebo+ Standard of Care · Chi-squared · p = 0.1223 · Mean difference (final values): 0.025

SecondaryViral Load

Changes from baseline in SARS-CoV-2 viral load at days 3, 7, 14, and 28.

Time frame:: at day 3,7,14,28
Reported as:: Mean · log10 copies/mL

Viral Load
log10 copies/mL	GT0918+ Standard of Care	Placebo+ Standard of Care
Days28	-5.4 ± 0.1	-4.9 ± 0.1
Days14	-4.8 ± 0.11	-4.5 ± 0.12
Days 7	-3.6 ± 0.12	-3.4 ± 0.13
Days 3	-2.0 ± 0.12	-1.5 ± 0.12

Statistical analysis

GT0918+ Standard of Care vs Placebo+ Standard of Care · t-test, 2 sided · p = 0.0038 · Mean difference (final values): 0.025

Adverse events

Collected over Up to day 42; the investigator (and/or designee) documented all AEs reported by the subject from the time subjects given consent through completion of the EOS visit (day42) per protocol. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
GT0918+ Standard of Care	0/365 (0%)	0/365 (0%)	19/365 (5.2%)
Placebo+ Standard of Care	1/365 (0.3%)	0/365 (0%)	11/365 (3%)

Most frequent other events

Most frequent other events
Event	GT0918+ Standard of Care	Placebo+ Standard of Care
DizzinessNervous system disorders	4/365	4/365
Abdominal pain upperGastrointestinal disorders	2/365	0/365
ParaesthesiaNervous system disorders	2/365	0/365
HallucinationPsychiatric disorders	2/365	0/365
VertigoNervous system disorders	2/365	2/365
Alanine aminotransferase increasedInvestigations	2/365	1/365
Platelet count decreasedInvestigations	2/365	0/365
Paraesthesia oralGastrointestinal disorders	2/365	0/365
Blood creatine phosphokinase increasedInvestigations	1/365	2/365
Fibrin D dimer increasedInvestigations	0/365	2/365

Baseline characteristics

Age, Continuous
Age, Continuous(years)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Mean	41 ± 13.82	40.9 ± 13.45	41 ± 13.63

Sex: Female, Male
Sex: Female, Male(Participants)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Female	183	185	368
Male	183	182	365

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Hispanic or Latino	322	325	647
Not Hispanic or Latino	44	42	86
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
American Indian or Alaska Native	1	1	2
Asian	1	3	4
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	25	33	58
White	323	316	639
More than one race	0	0	0
Unknown or Not Reported	16	13	29

BMI
BMI(kg/m^2)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Mean	29.02 ± 5.817	29.03 ± 6.625	29.02 ± 6.040

Vaccination Status
Vaccination Status(Participants)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Fully Vaccinated	140	152	292
Partially Vaccinated	14	16	30
Non Vaccinated	210	194	404
Unknown	2	5	7

COVID-19 Test Type
COVID-19 Test Type(Participants)	GT0918+ Standard of Care	Placebo+ Standard of Care	Total
Molecular (RNA or PCR) Test	228	236	464
Antigen (Rapid) Test	137	127	264
Unknown	1	4	5

Study locations

8 sites

Absolute Clinical Research
Phoenix, Arizona 85051, United States
Long Beach Clinical Trials
Long Beach, California 90806, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia 29677, United States
Olivo Medical and Wellness Center
Chicago, Illinois 60618, United States
Gtc Research
Shawnee Mission, Kansas 66218, United States
Platinum Research Network, LLC
Metairie, Louisiana 70006, United States
Main Street Physician's Care
Little River, South Carolina 29566, United States
Lotus Clinical Research
Houston, Texas 77024, United States

References and documents

Study documents

Study protocol · Jul 8, 2021
Statistical analysis plan · Mar 11, 2022
Informed consent form · Jul 9, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04870606
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,
Responsible party: Sponsor
First posted: May 3, 2021
Start date: Mar 5, 2021
Primary completion: Jan 24, 2022
Completion: Apr 6, 2022
Results posted: Jan 2, 2024
Last update: Jan 2, 2024

Study contacts

Wilson Lu

study director · Suzhou Kintor Pharmaceuticals,Inc.

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Suzhou Kintor Pharmaceutical Inc,

Start the discussion

Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria