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Antiandrogen

GT0918 for Coronavirus

Phase 3
Waitlist Available
Research Sponsored by Suzhou Kintor Pharmaceutical Inc,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days from enrollment
Awards & highlights

Study Summary

This trial will study whether Proxalutamide (GT0918) can help treat adults hospitalized with COVID-19. 762 subjects will be randomly assigned to either take GT0918 or a placebo, along with standard of care.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The time to Clinical deterioration is evaluated by Day 30.
Secondary outcome measures
60-day mortality

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT03899467
53%
Fatigue
47%
Decreased appetite
43%
Constipation
33%
Weight decreased
23%
Nausea
23%
Fall
23%
Oedema peripheral
13%
Hot flush
13%
Asthenia
13%
Diarrhoea
10%
Anaemia
10%
Haematuria
10%
Vomiting
10%
Muscular weakness
10%
Headache
10%
Dyspnoea
7%
Arthralgia
7%
Vertigo
7%
Hypoglycaemia
7%
Insomnia
7%
Confusional state
7%
Vision blurred
7%
Dizziness
7%
Atrial fibrillation
7%
Hiccups
7%
Dysgeusia
3%
Urinary tract infection
3%
Abdominal pain
3%
Pain in extremity
3%
Aspartate aminotransferase increased
3%
Neutropenic sepsis
3%
Blood lactate dehydrogenase increased
3%
Diverticulitis
3%
Rhabdomyolysis
3%
Alanine aminotransferase increased
3%
Anemia
3%
Hypotension
3%
Memory impairment
3%
Drug-induced liver injury
3%
Febrile neutropenia
3%
Neutropenia
3%
Hyponatraemia
3%
Dehydration
3%
COVID-19 pneumonia
3%
Visual impairment
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: 500 mg/Day of GT0918
Arm 1: 400 mg /Day of GT0918

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Proxalutamide (GT0918) plus standard of careExperimental Treatment2 Interventions
Participants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Group II: Placebo plus standard of carePlacebo Group2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GT0918
2019
Completed Phase 2
~110
Standard of care
2019
Completed Phase 4
~15850

Find a Location

Who is running the clinical trial?

Suzhou Kintor Pharmaceutical Inc,Lead Sponsor
14 Previous Clinical Trials
2,704 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I take GT0918, am I putting myself in harm's way?

"GT0918's safety is estimated to be a 3. This score was given because GT0918 is currently in Phase 3 trials, which means that while there is data supporting efficacy, multiple rounds of testing have yet to confirm its safety."

Answered by AI

What is the global scope of this experiment?

"To participate in this trial, you must visit one of the 8 active enrolment centres. These locations include Lansing and New york, as well as Hialeah and other cities. By enrolling at a location close to you, you can reduce travel time and costs."

Answered by AI

Does GT0918 have a history of successful clinical trials?

"GT0918 was first researched in 2021 at Medical City Fort Worth. As of now, there have been 182 completed trials with 1 more ongoing. The majority of these investigations are taking place in Lansing, Michigan."

Answered by AI

Is this a new clinical trial?

"Suzhou Kintor Pharmaceutical Inc's drug, GT0918, is currently being tested in a Phase 3 clinical trial. The study began in 2021 and has completed recruitment across 29 cities and 5 countries. A total of 762 patients have participated thus far."

Answered by AI

How many participants are being accepted into this research?

"In order to move forward with this clinical trial, 762 willing and eligible participants are required. If you meet the inclusion criteria, you may be able to take part in this study at Sparrow Hospital in Lansing, Michigan or Saint Lawrence Health System in New york, New York."

Answered by AI

Are people with the required qualifications able to participate in this research project at this time?

"That is correct. The trial, which began recruiting on September 30th 2021, is still looking for 762 patients from 8 different hospitals or clinics."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Alternative Research Associates LLC.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
2021. "A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05009732.
~40 spots leftby Apr 2025
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