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The rationale of the present clinical trial is that an orally available drug given to outpatients that could reduce the viral burden in the upper respiratory tract could forestall complications of SARS-CoV-2 infection and reduce transmission from one infected individual to another.
The study is designed as a double-blind randomized controlled clinical trial to test the hypothesis that camostat mesylate, a serine protease inhibitor shown to inhibit SARS-COV-2 replication in vitro, inhibits SARS-COV-2 replication in early stage, laboratory-confirmed, COVID-19 ambulatory patients.
Camostat mesylate, a serine protease inhibitor used primarily for treating postoperative reflux esophagitis and for acute exacerbations of chronic pancreatitis. This drug, with more than 15 years clinical experience in Japan with a very safe clinical track record, will be studied as a repurposed drug based on published in vitro virus inhibition data and in vivo protective effects in a mouse model of SARS.
The primary objective of this study is to determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camostat mesylate | Experimental | Camostat mesylate 200mg taken 7 days. |
|
| Placebo | Placebo Comparator | Placebo taken for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camostat Mesilate | Drug | Camostat mesilate 200mg taken orally, 4 times daily, for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SARS-COV-2 Viral Load | To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. | 5 days (day 0 to day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SARS-COV-2 Viral Load | To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. | 3 days (day 0 to day 2) |
| Change in SARS-COV-2 Viral Load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Chupp, M.D. | Director, Yale Center for Asthma and Airways Disease (YCAAD) | Principal Investigator |
| Joseph Vinetz, M.D. | Professor, Section of Infectious Diseases: Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35412356 | Derived | Kosinsky Y, Peskov K, Stanski DR, Wetmore D, Vinetz J. Semi-Mechanistic Pharmacokinetic-Pharmacodynamic Model of Camostat Mesylate-Predicted Efficacy against SARS-CoV-2 in COVID-19. Microbiol Spectr. 2022 Apr 27;10(2):e0216721. doi: 10.1128/spectrum.02167-21. Epub 2022 Apr 12. | |
| 35132421 | Derived | Chupp G, Spichler-Moffarah A, Sogaard OS, Esserman D, Dziura J, Danzig L, Chaurasia R, Patra KP, Salovey A, Nunez A, May J, Astorino L, Patel A, Halene S, Wang J, Hui P, Patel P, Lu J, Li F, Gan G, Parziale S, Katsovich L, Desir GV, Vinetz JM. A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial of Oral Camostat Mesylate for Early Treatment of COVID-19 Outpatients Showed Shorter Illness Course and Attenuation of Loss of Smell and Taste. medRxiv [Preprint]. 2022 Jan 31:2022.01.28.22270035. doi: 10.1101/2022.01.28.22270035. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Camostat Mesylate | Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days. |
| FG001 | Placebo | Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Camostat Mesylate | Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days. |
| BG001 | Placebo | Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days. |
| 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 | Change in SARS-COV-2 Viral Load | To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | log10 copies/mL | 5 days (day 0 to day 4) |
|
Up to 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 Mesylate | Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Chupp, MD Professor of Medicine (Pulmonary); Director, Yale Center for Asthma and Airways D | Yale School of Medicine | (203) 785-3627 | geoffrey.chupp@yale.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 | Aug 18, 2020 | Mar 1, 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 | Other | Placebo taken orally, 4 times daily, for 7 days. |
|
To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. |
| 7 days (day 0 to day 6) |
| Number of Participants With Change in Positive COVID-19 Status | Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm. | 7 days |
| Number of Participants With Change in Positive COVID-19 Status | Change in risk for a positive COVID-19 test at day 13 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm. | 14 days |
| Change in Positive COVID-19 Status | Number of Participants With Change in Positive COVID-19 Status | 28 days |
| Change in COVID-19 Symptom Severity | Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Day 0 to Day 6 |
| Change in COVID-19 Symptom Severity | Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Day 0 to Day 13 |
| Change in COVID-19 Symptom Frequency | Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms. | Day 0 to Day 6 |
| Change in COVID-19 Symptom Frequency | Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms. | Day 0 to Day 13 |
| Change in Body Temperature | Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | 7 days (Day 0 to Day 6) |
| Change in Body Temperature | Change of COVID-19 symptom score from baseline to 28 days will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | 28 days |
| 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 |
|
| Region of Enrollment | Number | participants |
|
Placebo taken for 7 days.
Placebo: Placebo taken orally, 4 times daily, for 7 days.
|
|
|
| Secondary | Change in SARS-COV-2 Viral Load | To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | log10 copies/mL | 3 days (day 0 to day 2) |
|
|
|
|
| Secondary | Change in SARS-COV-2 Viral Load | To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | log10 copies/mL | 7 days (day 0 to day 6) |
|
|
|
|
| Secondary | Number of Participants With Change in Positive COVID-19 Status | Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm. | Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 7 days. | Posted | Count of Participants | Participants | 7 days |
|
|
|
|
| Secondary | Number of Participants With Change in Positive COVID-19 Status | Change in risk for a positive COVID-19 test at day 13 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm. | Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 14 days. | Posted | Count of Participants | Participants | 14 days |
|
|
|
|
| Secondary | Change in Positive COVID-19 Status | Number of Participants With Change in Positive COVID-19 Status | Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 28 days. | Posted | Count of Participants | Participants | 28 days |
|
|
|
|
| Secondary | Change in COVID-19 Symptom Severity | Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 0 to Day 6 |
|
|
|
|
| Secondary | Change in COVID-19 Symptom Severity | Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 0 to Day 13 |
|
|
|
|
| Secondary | Change in COVID-19 Symptom Frequency | Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 0 to Day 6 |
|
|
|
|
| Secondary | Change in COVID-19 Symptom Frequency | Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms. | Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 0 to Day 13 |
|
|
|
|
| Secondary | Change in Body Temperature | Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Data are presented for those with valid temperature data. Body temperature was not evenly collected at all visits as originally intended. | Posted | Mean | Standard Deviation | degrees Fahrenheit | 7 days (Day 0 to Day 6) |
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|
|
| Secondary | Change in Body Temperature | Change of COVID-19 symptom score from baseline to 28 days will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit. | Data are presented for those with valid temperature data. Body temperature was not evenly collected at all visits as originally intended. | Posted | Mean | Standard Deviation | degrees Fahrenheit | 28 days |
|
|
|
| 0 |
| 35 |
| 2 |
| 35 |
| 3 |
| 35 |
| EG001 | Placebo | Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days. | 0 | 35 | 0 | 35 | 0 | 35 |
| Respiratory Infection | Respiratory, thoracic and mediastinal 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 |
| Negative |
|
| Saliva RT-PCR |
|
|
Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model. |
| 0.17 |
| Odds Ratio (OR) |
| 0.40 |
| 2-Sided |
| 95 |
| 0.11 |
| 1.47 |
| Superiority |
| Negative |
|
| Saliva RT-PCR |
|
|
| GEE |
Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model. |
| 0.68 |
| Odds Ratio (OR) |
| 1.23 |
| 2-Sided |
| 95 |
| 0.47 |
| 3.23 |
| Superiority |
| Negative |
|
| Saliva RT-PCR |
|
|
| GEE |
Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model. |
| 0.87 |
| Odds Ratio (OR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.25 |
| 3.23 |
| Superiority |
| Day 6 |
|
|
| Day 27 |
|
|