COVID-19 Clinical Trial
Official title:
The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
Verified date | May 2022 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Yale University | Ono Pharmaceutical Co. Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in plasma D-Dimer | The sum percent change in D-Dimer over 7 days will be compared to day 1 | 7 days | |
Secondary | Overall Safety and adverse event | The first assessment on mortality and complications will be carried out 3 months after the start of the study. | 3 months | |
Secondary | Change in plasma Fibrinogen levels | Percent change in fibrinogen over 7 days compared to day 1 | 7 days | |
Secondary | Change in plasma troponin | Percent change in troponin over 7 days compared to day 1 | 7 days | |
Secondary | New onset cardiomyopathy | New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured | 7 days | |
Secondary | Duration of intubation | Days with hypoxia (Room Air O2 Sat<93%) or days intubated | 7 days | |
Secondary | Length of stay in the intensive care unit | The number of days in the intensive care unit | 28 days | |
Secondary | Time to discharge from hospital | The number of days since admission to discharge | 30 days | |
Secondary | Occurrence of major adverse cardiovascular events | The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied. | 7 days |
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