Anti-Androgen Treatment for COVID-19

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Brief Title

Anti-Androgen Treatment for COVID-19

Official Title

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

Interventional


Primary Outcome

COVID-19 hospitalization

Secondary Outcome

 Symptoms severity of COVID-19

Condition

COVID-19

Intervention

Dutasteride

Study Arms / Comparison Groups

 Dutasteride + Standard Care
Description:  Ivermectin+ azythromycin + Dutasteride

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

254

Start Date

June 26, 2020

Completion Date

January 31, 2021

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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
      

Gender

Male

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Flavio A Cadegiani, MD, +5561996506111, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT04446429

Organization ID

AB-DRUG-SARS-004


Responsible Party

Sponsor

Study Sponsor

Applied Biology, Inc.


Study Sponsor

Flavio A Cadegiani, MD, Principal Investigator, Corpometria Institute


Verification Date

June 2020