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Camostat With Bicalutamide for COVID-19 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Camostat With Bicalutamide for COVID-19

COMBO Trial: Camostat With Bicalutamide for COVID-19

NCT04652765•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Summary

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).

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\>= 60 years of age
•COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=5 days from enrollment done in the ambulatory setting
•Able to provide informed consent
•Symptom related to COVID-19. This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.

Exclusion Criteria

•Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
•Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
•Unable to take oral medication
•Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
•Symptoms requiring hospitalization or immediate referral to hospital
•Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry
•Known hypersensitivity to bicalutamide, or camostat, or its components.
•On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
•Self-reported past medical history of chronic liver disease or cirrhosis
•Self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction \< 40%
+2 more criteria

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Key Dates

Start Date

February 3, 2021

Primary Completion Date

September 15, 2021

Completion Date

September 15, 2021

Last Updated

October 6, 2023

Enrollment

ACTUAL participants

Conditions

Covid19SARS-CoV InfectionCoronavirus Infection

Interventions

Camostat Mesilate

DRUG

Bicalutamide 150 mg

DRUG

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Long COVIDSars-CoV-2 Infection+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Camostat With Bicalutamide for COVID-19

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Covid-19 and Influenza Oral Vaccine Study

Post COVID-19 Biorepository

Conversations You Want About Corona Virus Disease (COVID-19)