- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524663
Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients (COPS-2003)
June 9, 2022 updated by: Stanford University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camostat mesilate
Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.
|
Camostat Mesilate administered as oral tablets
Other Names:
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.
|
Standard of Care Treatment for COVID-19 Infection
Placebo to match camostat mesilate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
Time Frame: Days 1-10
|
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.
|
Days 1-10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC of Shedding of SARS-CoV-2 Virus
Time Frame: Days 1-10, 14, 21, and 28
|
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.
|
Days 1-10, 14, 21, and 28
|
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 negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e.
no later positive results are observed).
|
Up to 28 days
|
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.
|
Up to 28 days
|
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.
|
Up to 28 days
|
Development of Antibodies to SARS-CoV-2
Time Frame: Up to 28 days
|
Number of patients that develop antibodies to SARS-CoV-2.
|
Up to 28 days
|
Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach
Time Frame: Day 5, 1 hour post dose
|
Day 5, 1 hour post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2020
Primary Completion (Actual)
May 15, 2021
Study Completion (Actual)
May 15, 2021
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
August 20, 2020
First Posted (Actual)
August 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Trypsin Inhibitors
- Camostat
Other Study ID Numbers
- 56029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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