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Trial record 1 of 1 for:    NCT04446429
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Anti-Androgen Treatment for COVID-19

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ClinicalTrials.gov Identifier: NCT04446429
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE July 2, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • COVID-19 hospitalization [ Time Frame: 30 days ]
    Percentage of subjects hospitalized due to COVID-19
  • COVID-19 Ordinal Outcomes Scale [ Time Frame: 30 days ]
    COVID Ordinal Scale defined as:
    1. Death
    2. Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation)
    3. Hospitalized on non-invasive ventilation or high flow nasal cannula
    4. Hospitalized on supplemental oxygen
    5. Hospitalized not on supplemental oxygen
    6. Not hospitalized with limitation in activity (continued symptoms)
    7. Not hospitalized without limitation in activity (no symptoms)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
Symptoms severity of COVID-19 [ Time Frame: 30 days ]
Symptoms severity of COVID-19 using Brescia-COVID Respiratory Severity Scale (BCRSS)/Algorithm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-Androgen Treatment for COVID-19
Official Title  ICMJE Anti-Androgen Treatment for COVID-19
Brief Summary This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Detailed Description

During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%).Among children under the age of 14, the rate of severe cases was reported to be extremely low. To explain this difference, several theories have been proposed including cigarette smoking and lifestyle habits. However, no theory fits both the gender difference in severe cases as well as reduced risk in pre-pubescent children. Our past research on male androgenetic alopecia (AGA) has led us to investigate an association between androgens and COVID-19 pathogenesis. In normal subjects, androgen expression demonstrates significant variation between men and women as well as between adults and pre-pubescent children.

SARS-CoV-2 primarily infects type II pneumocytes in the human lung. SARS-CoV-2 enters pneumocytes, by anchoring to the ACE2 cell surface receptor. Prior to receptor binding, viral spike proteins undergo proteolytic priming by the transmembrane protease, serine 2 (TMPRSS2). TMPRSS2 inhibition or knock down reduces ability of SARS-CoV-1 (a related virus to SARS-CoV-2) to infect cells in vitro. Additionally, TMPRSS2 also facilitates entry of influenza A and influenza B into primary human airway cells and type II pneumocytes.

The human TMPRSS2 gene has a 15 bp androgen response element and in humans, androgens are the only known transcription promoters for the TMPRSS2 gene. In a study of androgen-stimulated prostate cancer cells (LNCaP), TMPRSS2 mRNA expression increase was mediated by the androgen receptor. Further, the ACE2 receptor, also critical for SARS-CoV-2 viral infectivity, is affected by male sex hormones with higher activity found in males.

Androgenetic alopecia (AGA), often referred to as male pattern hair loss, is the most common form of hair loss among men. The development of androgenetic alopecia is androgen mediated and is dependent on genetic variants found in the androgen receptor gene located on the X chromosome; thus, it is hypothesized that men with AGA would be more prone to severe COVID-19 disease. The investigators conducted a preliminary observational study of hospitalized COVID-19 patients at two Spanish tertiary hospitals between March 23-April 6, 2020 to test this theory. In total, 41 Caucasian males admitted to the hospitals with a diagnosis of bilateral SARS-CoV-2 pneumonia were analyzed. The mean age of patients was 58 years (range 23-79). Among them, 29 (71%) were diagnosed with AGA (16 (39%) were classified as severe AGA (Hamilton IV or above)) and 12 (29%) did not present clinical signs of AGA. The diagnosis of AGA was performed clinically by a dermatologist. The precise prevalence of AGA among otherwise healthy Spanish Caucasian males is unknown; however, based on published literature, the expected prevalence of a similar age-matched Caucasian population is approximately 31-53%.

Based on the scientific rationale combined with this preliminary observation, the investigators propose to test an anti-androgen as a treatment for patients recently diagnosed with COVID-19. This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection. Provided anti-androgens are effective in reducing the rate of COVID-19 hospitalization, subjects enrolled in this study may experience a lower rate of hospitalization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • SARS-CoV2
  • Androgenetic Alopecia
  • Prostate Cancer
  • Benign Prostatic Hyperplasia
  • SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE
  • Drug: Dutasteride
    0.5 mg q.d.
  • Drug: Ivermectin
    200 mcg/kg q.d
  • Drug: Azithromycin
    500 mg q.d.
  • Drug: Proxalutamide
    200 mg q.d.
Study Arms  ICMJE
  • Experimental: Dutasteride + Standard Care
    Ivermectin+ Azythromycin + Dutasteride
    Interventions:
    • Drug: Dutasteride
    • Drug: Ivermectin
    • Drug: Azithromycin
  • Active Comparator: Standard Care
    Ivermectin + Azythromycin
    Interventions:
    • Drug: Ivermectin
    • Drug: Azithromycin
  • Experimental: Proxalutamide + Standard Care
    Ivermectin+ Azythromycin + Proxalutamide
    Interventions:
    • Drug: Ivermectin
    • Drug: Azithromycin
    • Drug: Proxalutamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2020)
381
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2020)
254
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male
  2. Age ≥50 years old
  3. Presenting "Gabrin sign" i.e., androgenetic alopecia (Norwood-Hamilton grade ≥ III)
  4. Positive SARS-CoV-2 rtPCR test in the past 7 days
  5. Not hospitalized for acute respiratory symptoms
  6. Willing to provide informed consent

Exclusion Criteria:

  1. Subject enrolled in a study to investigate a COVID-19 drug
  2. Subject taking an anti-androgen
  3. Hypothyroidism
  4. Not willing to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Flavio A Cadegiani, MD +5561996506111 f.cadegiani@gmail.com
Contact: Andy Goren, MD andyg@appliedbiology.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04446429
Other Study ID Numbers  ICMJE AB-DRUG-SARS-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Applied Biology, Inc.
Study Sponsor  ICMJE Applied Biology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Flavio A Cadegiani, MD Corpometria Institute
Study Director: Andy Goren, MD Applied Biology, Inc.
PRS Account Applied Biology, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP