Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: All

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. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19.

This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan; Yogendra Kanthi
• Treatments: Dipyridamole

Criteria

Inclusion Criteria:

• 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, enrolled ≤ 72 hours of hospital admission or of COVID-19 confirmation

• Currently hospitalized or anticipated hospitalization requiring supplemental oxygen ≤ 6 liters per minute (LPM) by nasal cannula

Exclusion Criteria:

• 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