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The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435015
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Arya Mani, Yale University

Brief Summary:
The primary aim of this study is to determine whether Camostat mesylate reduces SARS-COV-2 associated coagulopathy. Additional aims are to determine the effect of Camostat mesylate on SARS-COV-2 associated myocardial injury, to assess duration of hypoxia or intubation, to evaluate the length of intensive care unit and hospital stay, and assess mortality rates.

Condition or disease Intervention/treatment Phase
Coagulopathy Cardiovascular Complication COVID-19 Drug: Camostat Mesylate Drug: Microcrystalline Cellulose, NF Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Camostat mesylate 200 mg
Participants will be given Camostat mesylate three times daily.
Drug: Camostat Mesylate
Participants will be given Camostat mesylate three times daily.

Placebo Comparator: Microcrystalline Cellulose
Participants will be given placebo three times daily.
Drug: Microcrystalline Cellulose, NF
Participants will be given Microcrystalline Cellulose (placebo) three times daily.
Other Name: Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Change in plasma Fibrinogen levels [ Time Frame: 7 days ]
    Percent change in fibrinogen over 7 days compared to day 1

  3. Change in plasma troponin [ Time Frame: 7 days ]
    Percent change in troponin over 7 days compared to day 1

  4. 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

  5. Duration of intubation [ Time Frame: 7 days ]
    Days with hypoxia (Room Air O2 Sat<93%) or days intubated

  6. Length of stay in the intensive care unit [ Time Frame: 28 days ]
    The number of days in the intensive care unit

  7. Time to discharge from hospital [ Time Frame: 30 days ]
    The number of days since admission to discharge

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. . Positive COVID-19 test result.
  2. Diagnosis of COVID-19 associated coagulopathy and cardiac complications based on D-Dimer, fibrinogen, TnT, CTPE, ischemic EKG changes
  3. Provision of informed consent. In patients with altered mental status consents can be obtained from the power of attorney.
  4. Stated willingness to comply with all study procedures and availability for the duration of the study
  5. Male or female, age 18 or older
  6. Diagnosed with hypoxia requiring intubation or positive air pressure.
  7. Diagnose with DVT/PE by ultrasound and CTPE and/or
  8. Elevated D-Dimer and/or
  9. Greater than 2-fold increase in TnT
  10. Ischemic EKG changes with ST depression or elevation more than 1 mm in 2 consecutive leads
  11. Ability to administer oral medication.

Exclusion Criteria:

  1. GFR<30 mL/min
  2. Severe bleeding requiring blood transfusion of drop of 5% in HCT.
  3. Pregnancy or lactation
  4. Known allergic reactions to components of Camostat mesylate.
  5. Subjects under age 18

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): NCT04435015


Contacts
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Contact: Arya Mani, MD 203-785-4127 arya.mani@yale.edu
Contact: Arpita Neogi, MS 203-737-5500 arpita.neogi@yale.edu

Sponsors and Collaborators
Yale University
Ono Pharmaceutical Co. Ltd
Investigators
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Principal Investigator: Arya Mani, MD Yale University
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Responsible Party: Arya Mani, Professor of Medicine and of Genetics, Yale University
ClinicalTrials.gov Identifier: NCT04435015    
Other Study ID Numbers: 2000028279
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Study protocol and clinical study report will be shared 1 year after completion of the study

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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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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors