NCT04652765: COMBO

Camostat With Bicalutamide for COVID-19

Terminated Phase 1 Results posted Last updated 6 October 2023

What this trial tests

Phase 1 trial testing Camostat Mesilate in Covid19 in 6 participants. Terminated before completion.

Timeline

3 February 2021

Primary endpoint
15 September 2021

15 September 2021

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	3 February 2021
Primary completion	15 September 2021
Estimated completion	15 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Camostat Mesilate — full drug profile →
• Bicalutamide 150 mg — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• SARS-CoV Infection — all drugs for SARS-CoV Infection →
• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

60 and older, any sex, with Covid19 or SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Requiring Hospitalization Primary · up to 28 days

Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28

Group	Value	95% CI
Standard of Care (SOC)	0
SOC Plus Camostat	0
SOC Plus Camostat and Bicalutamide	0

Number of Participants Experiencing Symptoms Secondary · up to 21 days

Group	Value	95% CI
Standard of Care (SOC)	1
SOC Plus Camostat	2
SOC Plus Camostat and Bicalutamide	2

Number of Drug-related Adverse Events Secondary · up to 60 days

Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Group	Value	95% CI
Standard of Care (SOC)	0
SOC Plus Camostat	0
SOC Plus Camostat and Bicalutamide	1

Number of Drug-related Serious Adverse Events Secondary · up to 60 days

Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Group	Value	95% CI
Standard of Care (SOC)	0
SOC Plus Camostat	0
SOC Plus Camostat and Bicalutamide	0

All-cause Mortality Secondary · up to 60 days

Number of participants deceased.

Group	Value	95% CI
Standard of Care (SOC)	0
SOC Plus Camostat	0
SOC Plus Camostat and Bicalutamide	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care (SOC)

Serious: 0/1 (0%)

Deaths: 0/1

SOC Plus Camostat

Serious: 0/2 (0%)

Deaths: 0/2

SOC Plus Camostat and Bicalutamide

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (1 terms — click to expand)

Reaction	System	Standard of Care (SOC)	SOC Plus Camostat	SOC Plus Camostat and Bica…
Aspartate aminotransferase increased	Investigations	—	—	—

Data from ClinicalTrials.gov NCT04652765 adverse events section.

Sponsor's own description

This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).

Publications & conference data

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

1. The TMPRSS2 Inhibitor Nafamostat Reduces SARS-CoV-2 Pulmonary Infection in Mouse Models of COVID-19.
   Li K, Meyerholz DK, Bartlett JA, McCray PB. · · 2021 · cited 113× · PMID 34340553 · DOI 10.1128/mbio.00970-21
2. 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
3. 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
4. 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
5. Sex-tailored pharmacology and COVID-19: Next steps towards appropriateness and health equity.
   Spini A, Giudice V, Brancaleone V, Morgese MG, et al · · 2021 · cited 21× · PMID 34454035 · DOI 10.1016/j.phrs.2021.105848
6. The discovery and development of transmembrane serine protease 2 (TMPRSS2) inhibitors as candidate drugs for the treatment of COVID-19.
   Mantzourani C, Vasilakaki S, Gerogianni VE, Kokotos G. · · 2022 · cited 18× · PMID 35072549 · DOI 10.1080/17460441.2022.2029843
7. Roles of steroid receptors in the lung and COVID-19.
   Leach DA, Brooke GN, Bevan CL. · · 2021 · cited 11× · PMID 34328182 · DOI 10.1042/ebc20210005
8. A Review of Repurposed Cancer Drugs in Clinical Trials for Potential Treatment of COVID-19.
   Costa B, Vale N. · · 2021 · cited 7× · PMID 34070725 · DOI 10.3390/pharmaceutics13060815