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Camostat With Bicalutamide for COVID-19 (COMBO)

Primary Purpose

Covid19, SARS-CoV Infection, Coronavirus Infection

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Camostat Mesilate
Bicalutamide 150 mg
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%
  • Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.)

Women and people from all ethnic and race groups are eligible for this study.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard of care (SOC)

SOC plus camostat

SOC plus camostat and bicalutamide

Arm Description

SARS-CoV-2 positive participants will receive SOC therapy alone.

SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.

SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants Experiencing Symptoms
Number of Drug-related Adverse Events
Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Number of Drug-related Serious Adverse Events
Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
All-cause Mortality
Number of participants deceased.

Full Information

First Posted
December 2, 2020
Last Updated
October 5, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT04652765
Brief Title
Camostat With Bicalutamide for COVID-19
Acronym
COMBO
Official Title
COMBO Trial: Camostat With Bicalutamide for COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
PI Decision to close/stop the study due to no new accrual.
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV Infection, Coronavirus Infection
Keywords
COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care (SOC)
Arm Type
No Intervention
Arm Description
SARS-CoV-2 positive participants will receive SOC therapy alone.
Arm Title
SOC plus camostat
Arm Type
Active Comparator
Arm Description
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Arm Title
SOC plus camostat and bicalutamide
Arm Type
Active Comparator
Arm Description
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Intervention Type
Drug
Intervention Name(s)
Camostat Mesilate
Other Intervention Name(s)
camostat
Intervention Description
Camostat 600mg by mouth four times a day, for a total of 7 days
Intervention Type
Drug
Intervention Name(s)
Bicalutamide 150 mg
Intervention Description
Bicalutamide 150mg by mouth once daily, for a total of 7 days
Primary Outcome Measure Information:
Title
Number of Participants Requiring Hospitalization
Description
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Symptoms
Time Frame
up to 21 days
Title
Number of Drug-related Adverse Events
Description
Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Time Frame
up to 60 days
Title
Number of Drug-related Serious Adverse Events
Description
Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Time Frame
up to 60 days
Title
All-cause Mortality
Description
Number of participants deceased.
Time Frame
up to 60 days
Other Pre-specified Outcome Measures:
Title
Duration of Hospitalization
Description
Number of calendar days in the hospital
Time Frame
up to 60 days
Title
Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC)
Time Frame
up to 60 days
Title
Duration of IMC Stay
Description
Number of calendar days in IMC unit
Time Frame
up to 60 days
Title
Number of Participants Requiring Upgrade to Intensive Care Unit (ICU)
Time Frame
up to 60 days
Title
Duration of ICU Stay
Description
Number of calendar days in ICU
Time Frame
up to 60 days
Title
Number of Participants Requiring Mechanical Ventilation
Time Frame
up to 60 days
Title
Duration on Mechanical Ventilation
Description
Number of calendar days requiring mechanical ventilation
Time Frame
up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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% Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.) Women and people from all ethnic and race groups are eligible for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine H Marshall, MD/MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Camostat With Bicalutamide for COVID-19

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