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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04435015
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
200
Enrollment
2
Arms
2
Anticipated Duration (Months)

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/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 Names:
  • Placebo
  • Outcome Measures

    Primary Outcome Measures

    1. Percent change in plasma D-Dimer [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 [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 [7 days]

      Percent change in fibrinogen over 7 days compared to day 1

    3. Change in plasma troponin [7 days]

      Percent change in troponin over 7 days compared to day 1

    4. New onset cardiomyopathy [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 [7 days]

      Days with hypoxia (Room Air O2 Sat<93%) or days intubated

    6. Length of stay in the intensive care unit [28 days]

      The number of days in the intensive care unit

    7. Time to discharge from hospital [30 days]

      The number of days since admission to discharge

    8. Occurrence of major adverse cardiovascular events [7 days]

      The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yale University
    • Ono Pharmaceutical Co. Ltd

    Investigators

    • Principal Investigator: Arya Mani, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arya Mani, Professor of Medicine and of Genetics, Yale University
    ClinicalTrials.gov Identifier:
    NCT04435015
    Other Study ID Numbers:
    • 2000028279
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021