Proxalutamide Treatment for Hospitalized COVID-19 Patients

NCT04728802 | Completed Phase 3 Results DMC

• 1 other identifier: KP-DRUG-SARS-003
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to assess the efficacy and safety of Proxalutamide as a treatment for hospitalized COVID-19 male and female patients.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome)

Keywords

Proxalutamide; Androgen; Anti-androgen

Outcome Measures

Primary Outcomes (1)

• 14 Day Recovery Rate

  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 (3)

• 28 Day Recovery Rate

  Day 28

• 28 Day Mortality Rate

  28 days

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

  28 days

Study Arms (2)

Proxalutamide + Usual Care

ACTIVE COMPARATOR

Proxalutamide + usual care as determined by care provider

Drug: Proxalutamide

Placebo + Usual Care

PLACEBO COMPARATOR

Placebo + usual care as determined by care provider

Drug: Placebo

Interventions

Proxalutamide DRUG

Proxalutamide 300mg q.d

Proxalutamide + Usual Care

Placebo DRUG

Placebo pill

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
• Male and females age ≥18 years old
• Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
• 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, 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.

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (8)

Hospital Regional José Mendes

Itacoatiara, Amazonas, Brazil

Location

Hospital de Campanha de Manacapuru

Manacapuru, Amazonas, Brazil

Location

Hospital Oscar Nicolau

Manaus, Amazonas, Brazil

Location

Hospital Prontocord

Manaus, Amazonas, Brazil

Location

Hospital Samel

Manaus, Amazonas, Brazil

Location

Hospital Regional Dr. Hamilton Maia Cidae

Manicoré, Amazonas, Brazil

Location

Hospital Raimunda Francisca Dinelli da Silva

Maués, Amazonas, Brazil

Location

Hospital Regional Jofre Cohen

Parintins, Amazonas, Brazil

Location

Related Publications (6)

• Goren A, McCoy J, Wambier CG, Vano-Galvan S, Shapiro J, Dhurat R, Washenik K, Lotti T. What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy. Dermatol Ther. 2020 Jul;33(4):e13365. doi: 10.1111/dth.13365. Epub 2020 Apr 8. No abstract available.

  PMID: 32237190 BACKGROUND

• Goren A, Vano-Galvan S, Wambier CG, McCoy J, Gomez-Zubiaur A, Moreno-Arrones OM, Shapiro J, Sinclair RD, Gold MH, Kovacevic M, Mesinkovska NA, Goldust M, Washenik K. A preliminary observation: Male pattern hair loss among hospitalized COVID-19 patients in Spain - A potential clue to the role of androgens in COVID-19 severity. J Cosmet Dermatol. 2020 Jul;19(7):1545-1547. doi: 10.1111/jocd.13443. Epub 2020 Apr 23.

  PMID: 32301221 BACKGROUND

• Wambier CG, Vano-Galvan S, McCoy J, Gomez-Zubiaur A, Herrera S, Hermosa-Gelbard A, Moreno-Arrones OM, Jimenez-Gomez N, Gonzalez-Cantero A, Fonda-Pascual P, Segurado-Miravalles G, Shapiro J, Perez-Garcia B, Goren A. Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign". J Am Acad Dermatol. 2020 Aug;83(2):680-682. doi: 10.1016/j.jaad.2020.05.079. Epub 2020 May 22.

  PMID: 32446821 BACKGROUND

• Montopoli M, Zumerle S, Vettor R, Rugge M, Zorzi M, Catapano CV, Carbone GM, Cavalli A, Pagano F, Ragazzi E, Prayer-Galetti T, Alimonti A. Androgen-deprivation therapies for prostate cancer and risk of infection by SARS-CoV-2: a population-based study (N = 4532). Ann Oncol. 2020 Aug;31(8):1040-1045. doi: 10.1016/j.annonc.2020.04.479. Epub 2020 May 6.

  PMID: 32387456 BACKGROUND

• McCoy J, Cadegiani FA, Wambier CG, Herrera S, Vano-Galvan S, Mesinkovska NA, Ramos PM, Shapiro J, Sinclair R, Tosti A, Goren A. 5-alpha-reductase inhibitors are associated with reduced frequency of COVID-19 symptoms in males with androgenetic alopecia. J Eur Acad Dermatol Venereol. 2021 Apr;35(4):e243-e246. doi: 10.1111/jdv.17021. Epub 2020 Nov 22. No abstract available.

  PMID: 33135263 BACKGROUND

• McCoy J, Wambier CG, Herrera S, Vano-Galvan S, Gioia F, Comeche B, Ron R, Serrano-Villar S, Iwasiow RM, Tayeb MA, Cadegiani FA, Mesinkovska NA, Shapiro J, Sinclair R, Goren A. Androgen receptor genetic variant predicts COVID-19 disease severity: a prospective longitudinal study of hospitalized COVID-19 male patients. J Eur Acad Dermatol Venereol. 2021 Jan;35(1):e15-e17. doi: 10.1111/jdv.16956. Epub 2020 Oct 21. No abstract available.

  PMID: 32977355 BACKGROUND

Related Links

• The AndroCoV Project

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

Results Point of Contact

• Title: Dr. John McCoy
• Organization: Applied Biology, Inc.

johnm@appliedbiology.com

+1 (949)387-4526

Study Officials

• Flavio Cadegiani, MD

  Applied Biology, Inc.

  PRINCIPAL INVESTIGATOR

• Andy Goren, MD

  Applied Biology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: 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: January 27, 2021
• First Posted: January 28, 2021
• Study Start: February 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: June 24, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available upon request after peer review and publication.
• Access Criteria: Available upon request at data@appliedbiology.com

Locations

BR (8)