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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00254142 | Other Identifier | JHM IRB |
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PI Decision to close/stop the study due to no new accrual.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (SOC) | No Intervention | SARS-CoV-2 positive participants will receive SOC therapy alone. | |
| SOC plus camostat | Active Comparator | SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days. |
|
| SOC plus camostat and bicalutamide | Active Comparator | SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camostat Mesilate | Drug | Camostat 600mg by mouth four times a day, for a total of 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Hospitalization | Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28 | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Symptoms | up to 21 days | |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Number of calendar days in the hospital | up to 60 days |
| Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC) | up to 60 days |
Inclusion Criteria:
Exclusion Criteria:
Women and people from all ethnic and race groups are eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine H Marshall, MD/MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | SARS-CoV-2 positive participants will receive SOC therapy alone. |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | SARS-CoV-2 positive participants will receive SOC therapy alone. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Requiring Hospitalization | Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28 | Posted | Count of Participants | Participants | up to 28 days |
|
60 days
Only non COVID-19 adverse event were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | SARS-CoV-2 positive participants will receive SOC therapy alone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy Handy Marshall | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 4109550231 | chm@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2021 | Sep 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C034532 | camostat |
| C053541 | bicalutamide |
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| Bicalutamide 150 mg | Drug | Bicalutamide 150mg by mouth once daily, for a total of 7 days |
|
| up to 60 days |
| 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) | up to 60 days |
| All-cause Mortality | Number of participants deceased. | up to 60 days |
| Duration of IMC Stay | Number of calendar days in IMC unit | up to 60 days |
| Number of Participants Requiring Upgrade to Intensive Care Unit (ICU) | up to 60 days |
| Duration of ICU Stay | Number of calendar days in ICU | up to 60 days |
| Number of Participants Requiring Mechanical Ventilation | up to 60 days |
| Duration on Mechanical Ventilation | Number of calendar days requiring mechanical ventilation | up to 60 days |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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 |
|
|
| Secondary | Number of Participants Experiencing Symptoms | Posted | Count of Participants | Participants | up to 21 days |
|
|
|
| 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) | Posted | Count of Participants | Participants | up to 60 days |
|
|
|
| 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) | Posted | Count of Participants | Participants | up to 60 days |
|
|
|
| Secondary | All-cause Mortality | Number of participants deceased. | Posted | Count of Participants | Participants | up to 60 days |
|
|
|
| Other Pre-specified | Duration of Hospitalization | Number of calendar days in the hospital | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC) | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Duration of IMC Stay | Number of calendar days in IMC unit | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Number of Participants Requiring Upgrade to Intensive Care Unit (ICU) | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Duration of ICU Stay | Number of calendar days in ICU | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Number of Participants Requiring Mechanical Ventilation | Not Posted | up to 60 days | Participants |
| Other Pre-specified | Duration on Mechanical Ventilation | Number of calendar days requiring mechanical ventilation | Not Posted | up to 60 days | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 1 | 3 |
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |