A Randomized, Open-label Study of the Vascular and Microbiologic Efficacy of Dipyridamole Plus Standard Care vs. Standard Care in Hospitalized COVID19 Patients
Brief Summary: The goal here is to evaluate dipyridamole in treating respiratory tract infection and circulatory dysfunction due to SARS-CoV-2 coronavirus in hospitalized CVID-19 patients. Infection with SARS-CoV-2 causes human COVID-19 (HCoV-19). The infection is associated with a deleterious inflammatory response and a prothrombotic state in addition to tissue damage from direct viral entry and proliferation. Dipyridamole has anti-platelet and anti-inflammatory effects. The drug was recently demonstrated to have anti-SARS-Cov-2 effect primarily in vitro. The concentration causing anti-viral effect in vitro is within that in the blood of humans taking this drug. As an oral tablet, it has the advantage of easy administration. Anti thrombotic, anti viral and anti inflammatory actions of this drug may be efficacious and safe in hospitalized subjects
• Adults ≥18 years of age.
• COVID-19 positive by PCR and hospitalized for respiratory infection with a range of respiratory severity as follows.
• Moderate ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
• ● Symptoms of moderate illness with COVID-19, which could include:
• o Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms; shortness of breath with exertion
⁃ Clinical signs suggestive of moderate illness with COVID-19, such as:
‣ o RR ≥ 20, HR ≥ 90, SaO2 ≥93% on room air or requires ≤2L oxygen by nasal cannula (NC) in order maintain SaO2 ≥93%, fever \>38.3 Celsius
⁃ No clinical signs indicative of Severe or Critical Illness Severity
• Severe
⁃ Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
⁃ Symptoms suggestive of severe systemic illness with COVID-19, which could include:
‣ o any symptom of Moderate Illness; shortness of breath at rest or respiratory distress
⁃ Clinical signs indicative of severe systemic illness with COVID-19, such as
‣ o RR ≥ 30, HR ≥ 125, requires \> 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 \<300
⁃ No criteria for Critical Severity
• Critical ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
⁃ Evidence of critical illness, defined by at least 1 of the following:
• Respiratory failure defined based on resource utilization requiring at least 1 of the following:
• ◙, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
∙ Shock (defined by SBP \< 90 mm Hg, or Diastolic BP \< 60 mm Hg or requiring vasopressors)
∙ Multiple organ dysfunction/failure
• Able to give written informed consent in English to participate in the study by patient.