- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435015
The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial is in-patient only. Participants are identified by the hospital physicians and house staff, and contacted by research study personnel. Potential participants fulfilling inclusion criteria and not fulfilling exclusion criteria who agree to participate and sign the informed consent undergo the enrollment process. Ono Pharmaceutical, Japan, will provide Camostat mesylate tablets. The Yale New Haven Hospital research pharmacy will receive and store the drug within 15-25C range according to protocol storage requirements.
Microcrystalline Cellulose NF (PH-102) for placebo formulation will be acquired from Fagron. Empty gelatin capsules Size 0, for over-encapsulation will be acquired from Fagron. Before Ono Pharmaceutical can send the drug, an IND will be obtained from the FDA.
Principal Investigator and the Yale New Haven Hospital research pharmacy will keep accountability records for all investigational products acquired, dispensed, used and disposed. Drugs are administered by nurses. There will be no restriction on taking other medications, activities or food intake. There are two arms to the study: (a) pharmacy-formulated placebo 3 times a day (b) 200 mg Camostat mesylate to be taken three times daily. Each arm will have 100 subjects. All patients will receive treatment until discharged. Participants will be randomized equally to Camostat mesylate or identical appearing placebo using a permuted-block design with variable block size. The actual treatment assignment will be concealed from the investigators and the participants. The randomization scheme will be generated by the statistical group.
Participants have the option of refusing study drug. If the participant decides to stop the drug or blood drawing he or she would be dropped from the trial.
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- . Positive COVID-19 test result.
- Diagnosis of COVID-19 associated coagulopathy and cardiac complications based on D-Dimer, fibrinogen, TnT, CTPE, ischemic EKG changes
- Provision of informed consent. In patients with altered mental status consents can be obtained from the power of attorney.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
- Diagnosed with hypoxia requiring intubation or positive air pressure.
- Diagnose with DVT/PE by ultrasound and CTPE and/or
- Elevated D-Dimer and/or
- Greater than 2-fold increase in TnT
- Ischemic EKG changes with ST depression or elevation more than 1 mm in 2 consecutive leads
- Ability to administer oral medication.
Exclusion Criteria:
- GFR<30 mL/min
- Severe bleeding requiring blood transfusion of drop of 5% in HCT.
- Pregnancy or lactation
- Known allergic reactions to components of Camostat mesylate.
- Subjects under age 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camostat mesylate 200 mg
Participants will be given Camostat mesylate three times daily.
|
Participants will be given Camostat mesylate three times daily.
|
Placebo Comparator: Microcrystalline Cellulose
Participants will be given placebo three times daily.
|
Participants will be given Microcrystalline Cellulose (placebo) three times daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in plasma D-Dimer
Time Frame: 7 days
|
The sum percent change in D-Dimer over 7 days will be compared to day 1
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Safety and adverse event
Time Frame: 3 months
|
The first assessment on mortality and complications will be carried out 3 months after the start of the study.
|
3 months
|
Change in plasma Fibrinogen levels
Time Frame: 7 days
|
Percent change in fibrinogen over 7 days compared to day 1
|
7 days
|
Change in plasma troponin
Time Frame: 7 days
|
Percent change in troponin over 7 days compared to day 1
|
7 days
|
New onset cardiomyopathy
Time Frame: 7 days
|
New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured
|
7 days
|
Duration of intubation
Time Frame: 7 days
|
Days with hypoxia (Room Air O2 Sat<93%) or days intubated
|
7 days
|
Length of stay in the intensive care unit
Time Frame: 28 days
|
The number of days in the intensive care unit
|
28 days
|
Time to discharge from hospital
Time Frame: 30 days
|
The number of days since admission to discharge
|
30 days
|
Occurrence of major adverse cardiovascular events
Time Frame: 7 days
|
The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arya Mani, MD, Yale University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- COVID-19
- Hemostatic Disorders
- Blood Coagulation Disorders
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Trypsin Inhibitors
- Camostat
Other Study ID Numbers
- 2000028279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Camostat Mesylate
-
Cancer Research UKLatus TherapeuticsTerminatedCOVID-19 InfectionUnited Kingdom
-
Sagent Pharmaceuticals Inc.Completed
-
Seoul National University HospitalNot yet recruitingFontan Operation | Protein-Losing Enteropathy | Camostat Mesylate
-
Assistance Publique - Hôpitaux de ParisTerminated
-
Heinrich-Heine University, DuesseldorfThe Federal Ministry of Health, Germany (Bundesministerium für Gesundheit...CompletedCorona Virus Infection | SARS-CoV-2 Infection | SARS-CoV-2 Acute Respiratory Disease | SARS-CoV-2 PCR Test PositiveGermany
-
Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedCoronavirus Infection | Covid19 | SARS-CoV InfectionUnited States
-
Alan BryceUnknownSevere Acute Respiratory SyndromeUnited States
-
Stanford UniversityCompleted