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

Not Recruiting

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.

Official Title

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

Stanford Investigator(s)

Julie Parsonnet
Julie Parsonnet

George DeForest Barnett Professor of Medicine and Professor of Epidemiology and Population Health

Upinder Singh
Upinder Singh

Stanford Medicine Professor of Infectious Disease and Professor of Medicine (Infectious Diseases & Geographic Medicine) and of Microbiology and Immunology


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

   - 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

drug: Placebo

other: Standard of Care Treatment

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Study Team