Status:
COMPLETED
Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Lead Sponsor:
University of Michigan
Conditions:
COVID
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations....
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent prior to performing study procedures unless they have a legally authorized representative (LAR)
- Confirmed coronavirus (SARS-CoV-2) infection
- Currently hospitalized or anticipated hospitalization requiring supplemental oxygen
Exclusion
- In the opinion of at least two investigators, unlikely to survive for \>48 hours from screening
- Concurrent enrollment in a clinical trial with a cytokine inhibitor (targeting interleukin-6 (IL-6), Interleukin-6 Receptor (IL-6R), IL-1, or Janus kinase). Use of remdesivir is permitted.
- Currently on invasive mechanical ventilation.
- Hypotension defined as systolic blood pressure \< 90 mmHg on two sequential readings at least 4 hours apart
- Pregnant or breastfeeding
- Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylaxis or therapeutic dose is permitted)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, hemoglobin \< 8 grams per deciliter (g/dL), or platelets \<50,000 per cubic millimeter (mm3)
- History of recent major bleeding, defined in accordance with the criteria of the International Society on Thrombosis and Hemostasis (ISTH).
- Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
Key Trial Info
Start Date :
May 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04391179
Start Date
May 31 2020
End Date
February 22 2021
Last Update
March 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109