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

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Corona Virus Infection; SARS-CoV-2 Infection; COVID; Covid-19

Treatments: Drug: Dipyridamole 100 Milligram(mg); Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04391179

HUM00179783

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Currently hospitalized or anticipated hospitalization requiring supplemental oxygen

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 2 patient groups, including a placebo group

Dipyridamole 100 Milligram(mg)

Experimental group

Description:

100 milligrams (mg) by mouth (PO) four times a day (QID)

Treatment:

Drug: Dipyridamole 100 Milligram(mg)

Placebo

Placebo Comparator group

Description:

Placebo given by mouth four times a day

Treatment:

Drug: Placebo oral tablet