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To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Standard of Care | Placebo Comparator | Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. |
|
| Camostat + Standard of Care | Experimental | Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camostat Mesilate | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Alive and Free From Respiratory Failure | To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Alive and Free of Ventilator Use or ECMO | To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan H Bryce, M.D. | Academic and Community Cancer Research United | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Tucson Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Standard of Care | Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. |
| FG001 | Camostat + Standard of Care | Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. |
| BG001 | Camostat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients Alive and Free From Respiratory Failure | To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo. | All patients that submitted day 28 outcome data | Posted | Number | Proportion of patients | 28 Days |
|
56 days
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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 | Placebo | Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Haruo Bryce, M.D. | Mayo Clinic | (480)301-8335 | Bryce.Alan@mayo.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 | Mar 3, 2023 | Feb 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| C034532 | camostat |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | At Investigator discretion |
|
| Mortality Rate |
To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 days as compared to SOC treatment combined with placebo. |
| 28 Days |
| Clinical Change | Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change. | 28 Days |
| Adverse Event Grade 3 Plus Rate | Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized. | 28 days |
| Tucson |
| Arizona |
| 85712 |
| United States |
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|
| Secondary | Proportion of Patients Alive and Free of Ventilator Use or ECMO | To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo. | All patients that submitted day 28 outcome data | Posted | Number | Proportion of patients | 28 Days |
|
|
|
| Secondary | Mortality Rate | To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 days as compared to SOC treatment combined with placebo. | All patients that submitted day 28 outcome data | Posted | Number | proportion of participants | 28 Days |
|
|
|
| Secondary | Clinical Change | Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change. | Posted | Median | 95% Confidence Interval | Days | 28 Days |
|
|
|
| Secondary | Adverse Event Grade 3 Plus Rate | Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized. | All treated patients that were evaluated for adverse events. | Posted | Number | proportion of participants | 28 days |
|
|
|
| 4 |
| 50 |
| 4 |
| 50 |
| 16 |
| 50 |
| EG001 | Camostat | Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. | 3 | 50 | 2 | 50 | 21 | 50 |
| Infections and infestations - Oth spec | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12 | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | MedDRA 12 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12 | Systematic Assessment |
|
| Edema face | General disorders | MedDRA 12 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
|
| Gen disord and admin site conds-Oth spec | General disorders | MedDRA 12 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA 12 | Systematic Assessment |
|
| Herpes simplex reactivation | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Infections and infestations - Oth spec | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Shingles | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA 12 | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
|
| Renal and urinary disorders - Oth spec | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
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| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |