Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Condition: COVID; Corona Virus Infection; Covid-19; SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Intervention: Dipyridamole 100 Milligram(mg); Placebo oral tablet
Intervention description: Drug will be given for 14 days while in the hospital.; Placebo will be given for 14 days while in the hospital.
Intervention MeSH terms: Dipyridamole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oxygen

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.
    

Eligibility 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

          -  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