The South Proxa-Rescue AndroCoV Trial Against COVID-19

NCT05126628 | Completed Phase 3 DMC

• 1 other identifier: ProxaSouth
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Proxalutamide; Antiandrogens; Anti-androgens; TMPRSS2

Outcome Measures

Primary Outcomes (1)

• 14-Day Recovery Rate

  Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 14 days after randomization on the COVID-19 ordinal scale. The ordinal scale is defined as follows: 8\. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities

  Day 14

Secondary Outcomes (7)

• 28-Day Recovery Rate

  Day 28

• 14-Day All-Cause Mortality Rate

  Day 14

• 28-Day All-Cause Mortality Rate

  Day 28

• Post-Randomization Time to Recover (Alive Hospital Discharge)

  Day 28

• Proportion of subjects needing potent, large-spectrum antibiotics

  Day 28

Study Arms (2)

Active Comparator: Proxalutamide + Usual Care

ACTIVE COMPARATOR

Proxalutamide + usual care as determined by care provider

Drug: Proxalutamide

Placebo Comparator: Placebo + Usual Care

PLACEBO COMPARATOR

Placebo + usual care as determined by care provider

Drug: Placebo

Interventions

Proxalutamide DRUG

Proxalutamide 300mg q.d.(3 tablets of 100mg each) for 14 days.

Active Comparator: Proxalutamide + Usual Care

Placebo DRUG

Placebo 3 tablets q.d. for 14 days

Placebo Comparator: Placebo + Usual 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 within 7 days
• Male and females age ≥18 years old
• Laboratory confirmed positive SARS-CoV-2 rtPCR test
• Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 3, 4, 5, or 6
• 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
• Requires mechanical ventilation
• 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, uncontrolled hypothyroidism, uncontrolled 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.

Sponsors & Collaborators

• Corpometria Institute: lead
• Hospital da Brigada Militar de Porto Alegre, Porto Alegre, Brazil: collaborator
• Hospital Arcanjo Sao Miguel, Gramado, Brazil: collaborator
• Hospital Unimed Chapeco, Chapeco, Brazil: collaborator

Study Sites (1)

Corpometria Institute

Brasília, Federal District, 70390-150, Brazil

Location

MeSH Terms

Conditions

COVID-19

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• 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: November 7, 2021
• First Posted: November 19, 2021
• Study Start: March 6, 2021
• Primary Completion: March 16, 2021
• Study Completion: April 15, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

BR (1)