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.
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.
Drug: Camostat Mesylate
Participants will be given Camostat mesylate three times daily.
Drug: Microcrystalline Cellulose, NF
Participants will be given Microcrystalline Cellulose (placebo) three times daily.
Other Name: Placebo
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
Arya Mani, MD, Principal Investigator
Yale University