Proxalutamide Treatment for COVID-19 Female Outpatients

NCT04853134 | Withdrawn Phase 3

• 1 other identifier: AB-DRUG-SARS-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

Conditions

Covid19; SARS-CoV Infection

Keywords

Proxalutamide; Androgens

Outcome Measures

Primary Outcomes (1)

• COVID-19 hospitalization

  Percentage of subjects hospitalized due to COVID-19

  30 days

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Standard of care as determined by the PI

Other: Standard of Care

Proxalutamide + Standard Care

ACTIVE COMPARATOR

Proxalutamide + standard of care as determined by the PI

Drug: Proxalutamide

Interventions

Proxalutamide DRUG

200 mg q.d.

Proxalutamide + Standard Care

Standard of Care OTHER

Standard of care as determined by the PI

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a study in female subjects as an extension to NCT04446429 for male subjects
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female age \>=18 years old
• Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
• Clinical status on the NIAID COVID-19 Ordinal Scale of 1 or 2 (i.e., not requiring hospitalization)
• Coagulation: INR\<=1.5XULN, and APTT\<=1.5XULN
• Subject (or legally authorized representative) gives written informed consent prior to any study screening procedures
• Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study
• Not Pregnant or breastfeeding

You may not qualify if:

• Subject enrolled in a study to investigate a treatment for COVID-19 Page 17 of 40
• 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
• Subject unlikely to return for day 15 site visit for reasons other then remission
• Subject (or legally authorized representative) not willing or unable to provide informed consent
• Pregnant or breastfeeding

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Corpometria Institute

Brasília, 70390-150, Brazil

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

proxalutamide; Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Flavio Cadegiani, MD

  Corpometria Institute

  PRINCIPAL INVESTIGATOR

• Carlos Wambier, MD

  Applied Biology, Inc.

  PRINCIPAL INVESTIGATOR

• Andy Goren, MD

  Applied Biology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: 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 19, 2021
• First Posted: April 21, 2021
• Study Start: November 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2021-04

Locations

BR (1)