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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2021
  • participants needed
    120
  • sponsor
    Stanford University
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Updated on 26 January 2021
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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.

Details
Condition COVID19
Treatment Placebo, Standard of Care Treatment, Camostat Mesilate
Clinical Study IdentifierNCT04524663
SponsorStanford University
Last Modified on26 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have COVID19??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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