| Primary | Disease Progression at Day 28 | Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization. | The Intent-to-Treat population includes all subjects who were randomized | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.787 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Survival Rate | The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28). | | Posted | | Count of Participants | | Participants | | Up to Day 15 and Day 28 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Time to Fever Resolution | Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28. | | Posted | | Median | 95% Confidence Interval | Days | | Up to 28 days | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Resolution of Viral Shedding | Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination. | | Posted | | Count of Participants | | Participants | | Day 1, Day 7 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Rate of Adverse Events and Serious Adverse Events | Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28. | A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99). | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Cumulative Rate of Grade 3 and 4 Adverse Events | Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28. | A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99). | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Rate of Discontinuation | Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28). | The Intent-to-Treat (ITT) population includes all subjects who were randomized. | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Platelet Count | Clinical Laboratory Value of Platelet Count at Day 1 and Day 15 | The Intent-to Treat Population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | 10^9 platelets/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Potassium Level | Clinical laboratory value of Potassium Levels at Day 1 and Day 15 | | Posted | | Mean | Standard Deviation | mmol/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Aspartate Aminotransferase (AST) | Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | U/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Alanine Aminotransferase (ALT) | Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | U/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Alkaline Phosphatase (ALP) | Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | U/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | U/L | | Day 1 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Vital Signs - Heart Rate | Heart rate at Day 1, Day 7 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | Beats/Minute | | Day 1, Day 7 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Vital Signs - Blood Pressure | Blood pressure (BP) at Day 1, Day 7 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | mmHg | | Day 1, Day 7 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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| Secondary | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15 | The Intent-to-Treat population includes all subjects who were randomized. | Posted | | Mean | Standard Deviation | Percentage of SpO2 | | Day 1, Day 7 and Day 15 | | | | ID | Title | Description |
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| OG000 | Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | | OG001 | Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. |
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