Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: Camostat Mesilate
* Drug: Placebo
* Other: Standard of Care Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours prior to informed consent Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy Females must have a negative pregnancy test at screening Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol Exclusion Criteria: Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study. Previous use of antiviral drugs that may be active against Covid-19. Abnormal laboratory test results at screening: Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19. Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). Previously received camostat mesilate within the past 30 days. Advanced kidney disease Advanced liver disease History of alcohol or drug abuse in the previous 6 months. Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year). Taken another investigational drug within the past 30 days. Seemed by the Investigator to be ineligible for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camostat mesilate<br>Patients will receive camostat mesilate for 10 days in addition to standard of care treatment. | Drug: Camostat Mesilate<br>* Camostat Mesilate administered as oral tablets<br>* Other names: Foipan®;Other: Standard of Care Treatment<br>* Standard of Care Treatment for COVID-19 Infection<br>|
| Placebo Comparator: Placebo<br>Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment. | Drug: Placebo<br>* Placebo to match camostat mesilate<br>Other: Standard of Care Treatment<br>* Standard of Care Treatment for COVID-19 Infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |