Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Intervention: Camostat Mesilate; Placebo; Standard of Care Treatment
Intervention description: Camostat Mesilate administered as oral tablets; Placebo to match camostat mesilate; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Camostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.