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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Camostat Mesilate
Placebo
Standard of Care Treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Camostat mesilate

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.

Secondary Outcome Measures

AUC of Shedding of SARS-CoV-2 Virus
AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's Ct from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Time Until Cessation of Shedding of SARS-CoV-2 Virus
This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed).
Clinical Worsening of COVID-19 Disease in Symptomatic Patients
Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization.
Time Until Resolution of Symptoms
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.
Development of Antibodies to SARS-CoV-2
Number of patients that develop antibodies to SARS-CoV-2.
Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach

Full Information

First Posted
April 10, 2020
Last Updated
June 9, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04524663
Brief Title
Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients
Acronym
COPS-2003
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Camostat mesilate
Arm Type
Experimental
Arm Description
Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Intervention Type
Drug
Intervention Name(s)
Camostat Mesilate
Other Intervention Name(s)
Foipan®
Intervention Description
Camostat Mesilate administered as oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match camostat mesilate
Intervention Type
Other
Intervention Name(s)
Standard of Care Treatment
Intervention Description
Standard of Care Treatment for COVID-19 Infection
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
Description
AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Time Frame
Days 1-10
Secondary Outcome Measure Information:
Title
AUC of Shedding of SARS-CoV-2 Virus
Description
AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's Ct from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Time Frame
Days 1-10, 14, 21, and 28
Title
Time Until Cessation of Shedding of SARS-CoV-2 Virus
Description
This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed).
Time Frame
Up to 28 days
Title
Clinical Worsening of COVID-19 Disease in Symptomatic Patients
Description
Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization.
Time Frame
Up to 28 days
Title
Time Until Resolution of Symptoms
Description
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.
Time Frame
Up to 28 days
Title
Development of Antibodies to SARS-CoV-2
Description
Number of patients that develop antibodies to SARS-CoV-2.
Time Frame
Up to 28 days
Title
Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach
Time Frame
Day 5, 1 hour post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Parsonnet, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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