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This study will evaluate the efficacy of oral Foipan® (camostat mesilate) compared with the current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with mild-moderate COVID-19 disease.
Patients will attend 4 study visits over a period of up to 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camostat mesilate | Experimental | Patients will receive camostat mesilate for 10 days in addition to standard of care treatment. |
|
| Placebo | Placebo Comparator | Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camostat Mesilate | Drug | Camostat Mesilate administered as oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus | AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. | Days 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of Shedding of SARS-CoV-2 Virus | AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's Ct from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Parsonnet, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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After 49 participants were enrolled, this trial was subsumed into a pragmatic platform trial (the COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol (NCT04662073). Additional subjects subsequently consented for camostat in the platform study. Their results are not included here.
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| ID | Title | Description |
|---|---|---|
| FG000 | Camostat Mesilate | Camostat mesilate for 10 days in addition to standard of care treatment. |
| FG001 | Placebo | Placebo to match camostat mesilate for 10 days in addition to standard of care treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Camostat Mesilate | Camostat mesilate for 10 days in addition to standard of care treatment. |
| BG001 | Placebo | Placebo to match camostat mesilate for 10 days in addition to standard of care treatment. |
| 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 | Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus | AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. | Patients with nasal swab data are included in the analysis. | Posted | Median | Inter-Quartile Range | cycles*days | Days 1-10 |
|
28 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 | Camostat Mesilate | Camostat mesilate for 10 days in addition to standard of care treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function tests | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function test (LFT) elevation | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Parsonnet, MD | Stanford University | (650) 725-4561 | parsonnt@stanford.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 | Dec 4, 2020 | May 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C034532 | camostat |
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| Placebo | Drug | Placebo to match camostat mesilate |
|
| Standard of Care Treatment | Other | Standard of Care Treatment for COVID-19 Infection |
|
| Days 1-10, 14, 21, and 28 |
| Time Until Cessation of Shedding of SARS-CoV-2 Virus | This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed). | Up to 28 days |
| Clinical Worsening of COVID-19 Disease in Symptomatic Patients | Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization. | Up to 28 days |
| Time Until Resolution of Symptoms | This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline. | Up to 28 days |
| Development of Antibodies to SARS-CoV-2 | Number of patients that develop antibodies to SARS-CoV-2. | Up to 28 days |
| Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach | Day 5, 1 hour post dose |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Patient selected one of the options in a survey. Ethnicity was an optional survey item. | Participants who provided ethnicity data are included in the analysis. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Patient selected one of the options in a survey. Race was an optional survey item. | Participants who provided race data are included in the analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Anterior nares RT-PCR Ct | Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. RT-PCR: reverse transcription-polymerase chain reaction. | Participants with baseline data are included in the analysis. | Median | Inter-Quartile Range | cycles |
|
| Duration of Symptoms | Participants with baseline data are included in the analysis. | Median | Inter-Quartile Range | days |
|
| Number of Symptoms | Median | Inter-Quartile Range | symptoms |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Aspartate Aminotransferase | Median | Inter-Quartile Range | units/L |
|
| Alanine Aminotransferase | Median | Inter-Quartile Range | units/L |
|
| Uric acid | Participants with baseline data are included in the analysis. | Median | Inter-Quartile Range | mg/dL |
|
| Creatinine | Median | Inter-Quartile Range | mg/dL |
|
Camostat mesilate for 10 days in addition to standard of care treatment.
| OG001 | Placebo | Placebo to match camostat mesilate for 10 days in addition to standard of care treatment. |
|
|
|
| Secondary | AUC of Shedding of SARS-CoV-2 Virus | AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's Ct from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. | Patients with nasal swab data are included in the analysis. | Posted | Median | Inter-Quartile Range | cycles*days | Days 1-10, 14, 21, and 28 |
|
|
|
|
| Secondary | Time Until Cessation of Shedding of SARS-CoV-2 Virus | This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed). | Patients with nasal swab data are included in the analysis. | Posted | Median | Inter-Quartile Range | days | Up to 28 days |
|
|
|
|
| Secondary | Clinical Worsening of COVID-19 Disease in Symptomatic Patients | Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
|
| Secondary | Time Until Resolution of Symptoms | This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline. | Posted | Median | Inter-Quartile Range | days | Up to 28 days |
|
|
|
|
| Secondary | Development of Antibodies to SARS-CoV-2 | Number of patients that develop antibodies to SARS-CoV-2. | Data were not collected for this outcome measure. | Posted | Up to 28 days |
|
|
| Secondary | Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach | Data were not collected for this outcome measure. | Posted | Day 5, 1 hour post dose |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Placebo | Placebo to match camostat mesilate for 10 days in addition to standard of care treatment. | 0 | 24 | 3 | 24 | 10 | 24 |
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Suidical ideation | Psychiatric disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
|