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NCT04475601: COVIDENZA
Enzalutamide Treatment in COVID-19
Phase 2 trial testing Enzalutamide Pill in COVID-19 in 42 participants. Terminated before completion.
24 March 2021
Quick facts
| Lead sponsor | Andreas Josefsson |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 15 July 2020 |
| Primary completion | 24 March 2021 |
| Estimated completion | 29 May 2021 |
| Sites | 6 locations across Sweden |
Drugs / interventions tested
- Enzalutamide Pill — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
- Corona Virus Infection — all drugs for Corona Virus Infection →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04475601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04475601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Andreas Josefsson
- Last refreshed: 2 June 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing