Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit

NCT04853927 | Withdrawn Phase 3

• 1 other identifier: KP-DRUG-SARS-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of Proxalutamide as a treatment for COVID-19 patients in the intensive care unit

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome)

Keywords

Proxalutamide; Androgen; Anti-androgen

Outcome Measures

Primary Outcomes (1)

• Proportion of death

  Defined as the number of subjects who have died in each arm divided by the number of subjects randomized to the treatment arm

  Day 28

Study Arms (2)

Proxalutamide + Standard of Care

ACTIVE COMPARATOR

Proxalutamide + standard of care as determined by the PI

Drug: Proxalutamide

Placebo + Standard Care

PLACEBO COMPARATOR

Placebo + Standard of care as determined by the PI

Drug: Placebo

Interventions

Proxalutamide DRUG

Proxalutamide 300mg q.d suspension

Proxalutamide + Standard of Care

Placebo DRUG

Proxalutamide 300mg q.d placebo

Placebo + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the hospital with symptoms of COVID-19
• Male and females age ≥18 years old
• Laboratory confirmed positive SARS-CoV-2 rtPCR test within 14 days prior to randomization or confirmed lung involvement by CT scan
• Clinical status on the COVID-19 Ordinal Scale of 6 or 7
• Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN
• Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
• Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study

You may not qualify if:

• Subject enrolled in a study to investigate a treatment for COVID-19
• Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…
• Patients who are allergic to the investigational product or similar drugs (or any excipients);
• Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type
• Subjects with known serious cardiovascular diseases, congenital long QT syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular ejection fraction (LVEF) \< 50%, QTcF \> 450 ms
• Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)
• Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory）
• Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min
• Severe kidney disease requiring dialysis
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include:
• Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or
• Use of one of the following combinations (a+b or a+c or b+c):
• Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS) ;

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Samel Hospital

Manaus, Amazonas, Brazil

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

proxalutamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Fonseca, MD

  Samel Hospital

  PRINCIPAL INVESTIGATOR

• Flavio Cadegiani, MD

  Corpometria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 22, 2021
• Study Start: February 8, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2021-02

Locations

BR (1)