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

NCT04435015 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 2000028279
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coagulopathy; Cardiovascular Complication; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Overall Safety and adverse event

  3 months

• Change in plasma Fibrinogen levels

  7 days

• Change in plasma troponin

  7 days

• New onset cardiomyopathy

  7 days

• Duration of intubation

  7 days

Study Arms (2)

Camostat mesylate 200 mg

EXPERIMENTAL

Participants will be given Camostat mesylate three times daily.

Drug: Camostat Mesylate

Microcrystalline Cellulose

PLACEBO COMPARATOR

Participants will be given placebo three times daily.

Drug: Microcrystalline Cellulose, NF

Interventions

Camostat Mesylate DRUG

Participants will be given Camostat mesylate three times daily.

Camostat mesylate 200 mg

Microcrystalline Cellulose, NF DRUG

Participants will be given Microcrystalline Cellulose (placebo) three times daily.

Also known as: Placebo

Microcrystalline Cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Ono Pharmaceutical Co. Ltd: collaborator

MeSH Terms

Conditions

Hemostatic Disorders; COVID-19

Interventions

camostat; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arya Mani, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and of Genetics

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study protocol and clinical study report will be shared 1 year after completion of the study