Trial Outcomes & Findings for Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness (NCT NCT04870606)

Last Updated: 2024-01-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

733 participants

Primary outcome timeframe

28 days

Results posted on

2024-01-02

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

733 subjects were randomized. 366 subjects were assigned to receive Pruxelutamide arm and 367 subjects were assigned to receive placebo arm. All randomized subjects were included in the ITT population. 730 subjects, which included 365 subjects from each of the Pruxelutamide and placebo groups, were randomized and received at least one dose of treatment. These subjects were included in both the mITT and SS populations.

Participant milestones

Participant milestones
Measure	GT0918+ Standard of Care Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care Placebo: Placebo+Standard of care determined by PI and local regulatory
Overall Study STARTED	366	367
Overall Study Received at Least One Dose of Treatment After Randomised	365	365
Overall Study COMPLETED	354	359
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GT0918+ Standard of Care n=366 Participants Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=367 Participants Placebo: Placebo+Standard of care determined by PI and local regulatory	Total n=733 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 13.82 • n=5 Participants	40.9 years STANDARD_DEVIATION 13.45 • n=7 Participants	41 years STANDARD_DEVIATION 13.63 • n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	185 Participants n=7 Participants	368 Participants n=5 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	182 Participants n=7 Participants	365 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	322 Participants n=5 Participants	325 Participants n=7 Participants	647 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	42 Participants n=7 Participants	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	323 Participants n=5 Participants	316 Participants n=7 Participants	639 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
BMI	29.02 kg/m^2 STANDARD_DEVIATION 5.817 • n=5 Participants	29.03 kg/m^2 STANDARD_DEVIATION 6.625 • n=7 Participants	29.02 kg/m^2 STANDARD_DEVIATION 6.040 • n=5 Participants
Vaccination Status Fully Vaccinated	140 Participants n=5 Participants	152 Participants n=7 Participants	292 Participants n=5 Participants
Vaccination Status Partially Vaccinated	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Vaccination Status Non Vaccinated	210 Participants n=5 Participants	194 Participants n=7 Participants	404 Participants n=5 Participants
Vaccination Status Unknown	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
COVID-19 Test Type Molecular (RNA or PCR) Test	228 Participants n=5 Participants	236 Participants n=7 Participants	464 Participants n=5 Participants
COVID-19 Test Type Antigen (Rapid) Test	137 Participants n=5 Participants	127 Participants n=7 Participants	264 Participants n=5 Participants
COVID-19 Test Type Unknown	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: In mITT (administrated at least one dose)

Outcome measures

Outcome measures
Measure	GT0918+ Standard of Care n=365 Participants Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=365 Participants Placebo: Placebo+Standard of care determined by PI and local regulatory
Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo	361 Participants	357 Participants

PRIMARY outcome

Timeframe: 28 days

Population: mITT (treatment period \>7 days) The mITT was defined as patients treated at least one dose. The primary outcome was analyzed based on mITT set. At the same time, the sponsor did some sensitive analysis based on another mITT set, defined as patients treated longer than 7 days, to support the primary outcome analysis.

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

Outcome measures

Outcome measures
Measure	GT0918+ Standard of Care n=348 Participants Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=345 Participants Placebo: Placebo+Standard of care determined by PI and local regulatory
Sensitivity Analysis to Evaluate Efficacy in Terms of Clinical Status Following Treatment With Pruxelutamide (GT0918) Compared to Placebo	348 Participants	339 Participants

SECONDARY outcome

Timeframe: 28 days

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

Outcome measures

Outcome measures
Measure	GT0918+ Standard of Care n=365 Participants Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=365 Participants Placebo: Placebo+Standard of care determined by PI and local regulatory
Proportion of Subjects With Hospitalization by Day 28	4 Participants	8 Participants

SECONDARY outcome

Timeframe: at day 3,7,14,28

Population: The patient enrolled by local laboratory-confirmed SARS-CoV-2 infection; at the same time, Quantitative RT-qPCR done in the central laboratory was to determine the viral load change from different time points." Only the patients with positive dd-PCR test results, Limit of Detection with 59.9 copies/mL, were included in the viral load analysis, 277 patients in GT0918 group and 272 patients in placebo group.

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

Outcome measures

Outcome measures
Measure	GT0918+ Standard of Care n=277 Participants Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=272 Participants Placebo: Placebo+Standard of care determined by PI and local regulatory
Viral Load Days28	-5.4 log10 copies/mL Standard Error 0.1	-4.9 log10 copies/mL Standard Error 0.1
Viral Load Days14	-4.8 log10 copies/mL Standard Error 0.11	-4.5 log10 copies/mL Standard Error 0.12
Viral Load Days 7	-3.6 log10 copies/mL Standard Error 0.12	-3.4 log10 copies/mL Standard Error 0.13
Viral Load Days 3	-2.0 log10 copies/mL Standard Error 0.12	-1.5 log10 copies/mL Standard Error 0.12

Adverse Events

GT0918+ Standard of Care

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo+ Standard of Care

Serious events: 0 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GT0918+ Standard of Care n=365 participants at risk Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory	Placebo+ Standard of Care n=365 participants at risk Placebo: Placebo+Standard of care determined by PI and local regulatory
Gastrointestinal disorders Abdominal pain upper	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Nervous system disorders Paraesthesia	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Nervous system disorders Dizziness	1.1% 4/365 • Number of events 4 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	1.1% 4/365 • Number of events 4 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Psychiatric disorders Hallucination	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Nervous system disorders Vertigo	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Investigations Alanine aminotransferase increased	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.27% 1/365 • Number of events 1 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Investigations Platelet count decreased	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Gastrointestinal disorders Paraesthesia oral	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Investigations Blood creatine phosphokinase increased	0.27% 1/365 • Number of events 1 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Investigations Fibrin D dimer increased	0.00% 0/365 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.	0.55% 2/365 • Number of events 2 • 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 If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.

Additional Information

Millie Gu

Suzhou Kintor Pharmaceuticals,Inc.

Phone: +86- 512 6263 9938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place