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Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients
Trial ID: NCT04524663
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.
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
- 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
- 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
- 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
- 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.
drug: Camostat Mesilate
other: Standard of Care Treatment
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