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

NCT ID: NCT04524663

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-19
• Study Completion Date: 2021-05-15

Brief 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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Camostat mesilate

Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.

Group Type: EXPERIMENTAL

Camostat Mesilate

Intervention Type: DRUG

Camostat Mesilate administered as oral tablets

Standard of Care Treatment

Intervention Type: OTHER

Standard of Care Treatment for COVID-19 Infection

Placebo

Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match camostat mesilate

Standard of Care Treatment

Intervention Type: OTHER

Standard of Care Treatment for COVID-19 Infection

Interventions

Camostat Mesilate

Camostat Mesilate administered as oral tablets

Intervention Type: DRUG

Placebo

Placebo to match camostat mesilate

Intervention Type: DRUG

Standard of Care Treatment

Standard of Care Treatment for COVID-19 Infection

Intervention Type: OTHER

Other Intervention Names

Foipan®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Parsonnet, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

56029

Identifier Type: -

Identifier Source: org_study_id