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NCT04475601: COVIDENZA

Enzalutamide Treatment in COVID-19

Terminated Phase 2 Last updated 2 June 2022
What this trial tests

Phase 2 trial testing Enzalutamide Pill in COVID-19 in 42 participants. Terminated before completion.

Timeline
15 July 2020
Primary endpoint
24 March 2021
29 May 2021

Quick facts

Lead sponsorAndreas Josefsson
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment42
Start date15 July 2020
Primary completion24 March 2021
Estimated completion29 May 2021
Sites6 locations across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Andreas Josefsson — full company profile →

Who can join

50 and older, any sex, with COVID-19 or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. COVID-19 and Cancer: Current Challenges and Perspectives.
    Bakouny Z, Hawley JE, Choueiri TK, Peters S, et al · · 2020 · cited 201× · PMID 33049215 · DOI 10.1016/j.ccell.2020.09.018
  2. Targeting transcriptional regulation of SARS-CoV-2 entry factors <i>ACE2</i> and <i>TMPRSS2</i>.
    Qiao Y, Wang XM, Mannan R, Pitchiaya S, et al · · 2021 · cited 155× · PMID 33310900 · DOI 10.1073/pnas.2021450118
  3. Wuhan to World: The COVID-19 Pandemic.
    Kumar A, Singh R, Kaur J, Pandey S, et al · · 2021 · cited 109× · PMID 33859951 · DOI 10.3389/fcimb.2021.596201
  4. Targeting androgen regulation of TMPRSS2 and ACE2 as a therapeutic strategy to combat COVID-19.
    Deng Q, Rasool RU, Russell RM, Natesan R, et al · · 2021 · cited 82× · PMID 33681723 · DOI 10.1016/j.isci.2021.102254
  5. Androgen regulation of pulmonary AR, TMPRSS2 and ACE2 with implications for sex-discordant COVID-19 outcomes.
    Baratchian M, McManus JM, Berk MP, Nakamura F, et al · · 2021 · cited 79× · PMID 34045511 · DOI 10.1038/s41598-021-90491-1
  6. Distinct mechanisms for TMPRSS2 expression explain organ-specific inhibition of SARS-CoV-2 infection by enzalutamide.
    Li F, Han M, Dai P, Xu W, et al · · 2021 · cited 77× · PMID 33558541 · DOI 10.1038/s41467-021-21171-x
  7. Role of miR-2392 in driving SARS-CoV-2 infection.
    McDonald JT, Enguita FJ, Taylor D, Griffin RJ, et al · · 2021 · cited 75× · PMID 34624208 · DOI 10.1016/j.celrep.2021.109839
  8. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04475601.

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