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Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients (COPS-2003)

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ClinicalTrials.gov Identifier: NCT04524663
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Camostat Mesilate Drug: Placebo Other: Standard of Care Treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2020
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 15, 2021

Arm Intervention/treatment
Experimental: Camostat mesilate
Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.
Drug: Camostat Mesilate
Camostat Mesilate administered as oral tablets
Other Name: Foipan®

Other: Standard of Care Treatment
Standard of Care Treatment for COVID-19 Infection

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

Other: Standard of Care Treatment
Standard of Care Treatment for COVID-19 Infection




Primary Outcome Measures :
  1. Time until cessation of shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ]
    This outcome is defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.


Secondary Outcome Measures :
  1. Clinical worsening of COVID-19 disease in symptomatic patients [ Time Frame: Up to 28 days ]
    Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization.

  2. Development of antibodies to SARS-CoV-2 [ Time Frame: Up to 28 days ]
    Number of patients that develop antibodies to SARS-CoV-2.

  3. Time until resolution of symptoms [ Time Frame: Up to 28 days ]
    This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline

  4. Time until progression of symptoms [ Time Frame: Up to 28 days ]
    Progression of respiratory symptoms defined as a two-level increase of a symptom on the Daily Symptom Status Questionnaire within a 24 hour period, or a one-level increase of a symptom on the Daily Symptom Status Questionnaire observed/sustained for a consecutive 48 hour period.

  5. Drug level on day five, one hour after a dose taken on an empty stomach [ Time Frame: Day 5, 1 hour post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524663


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Julie Parsonnet, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04524663    
Other Study ID Numbers: 56029
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors