Covid19, SARS-CoV Infection, Coronavirus Infection
Conditions
Keywords
COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2
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).
Interventions
Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150mg by mouth once daily, for a total of 7 days
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Hospitalization | up to 28 days | Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Symptoms | up to 21 days | — |
| Number of Drug-related Adverse Events | 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) |
| Number of Drug-related Serious Adverse Events | 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) |
| All-cause Mortality | up to 60 days | Number of participants deceased. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC) | up to 60 days | — |
| Number of Participants Requiring Upgrade to Intensive Care Unit (ICU) | up to 60 days | — |
| Duration of IMC Stay | up to 60 days | Number of calendar days in IMC unit |
| Duration of ICU Stay | up to 60 days | Number of calendar days in ICU |
| Number of Participants Requiring Mechanical Ventilation | up to 60 days | — |
| Duration on Mechanical Ventilation | up to 60 days | Number of calendar days requiring mechanical ventilation |
| Duration of Hospitalization | up to 60 days | Number of calendar days in the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SOC) SARS-CoV-2 positive participants will receive SOC therapy alone. | 1 |
| SOC Plus Camostat SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days | 2 |
| SOC Plus Camostat and Bicalutamide SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Standard of Care (SOC) | SOC Plus Camostat | SOC Plus Camostat and Bicalutamide | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 61 years | 62.5 years | 61 years | 61.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 0 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Number of Participants Requiring Hospitalization
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Time frame: up to 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | Number of Participants Requiring Hospitalization | 0 Participants |
| SOC Plus Camostat | Number of Participants Requiring Hospitalization | 0 Participants |
| SOC Plus Camostat and Bicalutamide | Number of Participants Requiring Hospitalization | 0 Participants |
Secondary
All-cause Mortality
Number of participants deceased.
Time frame: up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | All-cause Mortality | 0 Participants |
| SOC Plus Camostat | All-cause Mortality | 0 Participants |
| SOC Plus Camostat and Bicalutamide | All-cause Mortality | 0 Participants |
Secondary
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)
Time frame: up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | Number of Drug-related Adverse Events | 0 Participants |
| SOC Plus Camostat | Number of Drug-related Adverse Events | 0 Participants |
| SOC Plus Camostat and Bicalutamide | Number of Drug-related Adverse Events | 1 Participants |
Secondary
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)
Time frame: up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | Number of Drug-related Serious Adverse Events | 0 Participants |
| SOC Plus Camostat | Number of Drug-related Serious Adverse Events | 0 Participants |
| SOC Plus Camostat and Bicalutamide | Number of Drug-related Serious Adverse Events | 0 Participants |
Secondary
Number of Participants Experiencing Symptoms
Time frame: up to 21 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) | Number of Participants Experiencing Symptoms | 1 Participants |
| SOC Plus Camostat | Number of Participants Experiencing Symptoms | 2 Participants |
| SOC Plus Camostat and Bicalutamide | Number of Participants Experiencing Symptoms | 2 Participants |
Other Pre-specified
Duration of Hospitalization
Number of calendar days in the hospital
Time frame: up to 60 days
Other Pre-specified
Duration of ICU Stay
Number of calendar days in ICU
Time frame: up to 60 days
Other Pre-specified
Duration of IMC Stay
Number of calendar days in IMC unit
Time frame: up to 60 days
Other Pre-specified
Duration on Mechanical Ventilation
Number of calendar days requiring mechanical ventilation
Time frame: up to 60 days
Other Pre-specified
Number of Participants Requiring Mechanical Ventilation
Time frame: up to 60 days
Other Pre-specified
Number of Participants Requiring Upgrade to Intensive Care Unit (ICU)
Time frame: up to 60 days
Other Pre-specified
Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC)
Time frame: up to 60 days