NCT04509999

Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Withdrawn Phase 3 Last updated 1 July 2021

What this trial tests

Phase 3 trial testing Bicalutamide 150 Mg Oral Tablet in COVID-19. Withdrawn.

Timeline

26 October 2020

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	University of Florida
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	26 October 2020
Primary completion	30 June 2021
Estimated completion	30 June 2021

Drugs / interventions tested

• Bicalutamide 150 Mg Oral Tablet
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Florida

Who can join

Adults 18 to 99, male only, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.

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. 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
4. 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
5. The intersection of COVID-19 and cancer: signaling pathways and treatment implications.
   Zong Z, Wei Y, Ren J, Zhang L, et al · · 2021 · cited 54× · PMID 34001144 · DOI 10.1186/s12943-021-01363-1
6. Cardiovascular Toxicities of Androgen Deprivation Therapy.
   Challa AA, Calaway AC, Cullen J, Garcia J, et al · · 2021 · cited 37× · PMID 33866442 · DOI 10.1007/s11864-021-00846-z
7. Sex hormones in SARS-CoV-2 susceptibility: key players or confounders?
   Lott N, Gebhard CE, Bengs S, Haider A, et al · · 2023 · cited 30× · PMID 36494595 · DOI 10.1038/s41574-022-00780-6
8. The Physiological Mechanisms of the Sex-Based Difference in Outcomes of COVID19 Infection.
   Wray S, Arrowsmith S. · · 2021 · cited 28× · PMID 33633588 · DOI 10.3389/fphys.2021.627260