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

  • STATUS
    Recruiting
  • End date
    Jan 24, 2022
  • participants needed
    668
  • sponsor
    Suzhou Kintor Pharmaceutical Inc,
Updated on 23 May 2021

Summary

The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.

Details
Condition Efficacy and Safety
Treatment Placebo, Proxalutamide (GT0918)
Clinical Study IdentifierNCT04870606
SponsorSuzhou Kintor Pharmaceutical Inc,
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

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. 8. Agree to the collection of nasopharyngeal swabs and venous blood

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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