Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    UConn Health
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Updated on 16 February 2024
See if I qualify
critical illness
shock
inflammatory response
fever
pao2
FIO2
dyspnea
respiratory distress
cough
headache
intermittent positive pressure ventilation
pharyngitis
gastrointestinal symptoms
malaise
myalgia
SARS
vasoconstrictor
critically ill
respiratory failure
sore throat
respiratory tract infection
coronavirus infection
fraction of inspired oxygen (fio2)
throat
acute respiratory syndrome (sars)

Summary

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

Details
Condition Vascular Complications, COVID-19 Pneumonia
Age 18years - 100years
Treatment Dipyridamole
Clinical Study IdentifierNCT04424901
SponsorUConn Health
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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
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
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
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 3\. Able to give written informed consent in English to participate in the study by patient
\-

Exclusion Criteria

Exclusion Criteria
Inability to swallow or ingest oral medication in either tablet form or in suspension form
Patient is known to be pregnant
Patients with a history of allergy or hypersensitivity to dipyridamole
Patient is unable to consent -intubated, on mechanical ventilation
Bleeding disorders (e.g. thrombocytopenia with platelet counts < 50,000)
Existing severe medical illnesses unrelated to Covid-19 infection such as end stage heart, kidney, liver disorders
or hepatic insufficiency defined as liver enzymes 5 times upper limit normal
if baseline is normal or 5 times baseline if baseline is abnormal
Metastatic cancer as well as those with severe coronary artery disease
unstable angina, STEMI, NSTEMI, hypotension (systolic blood pressure <90mmHg)
myocarditis, bradycardia with resting heart rate less than 60 bpm
atrioventricular block without pacemaker
Those with myasthenia gravis and those treated with cholinesterase inhibitors
\. Patient is enrolled in a clinical trial for another investigational drug
designed to test for efficacy for SARS-CoV-2
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critical illness
shock
inflammatory response
fever
pao2
FIO2
dyspnea
respiratory distress
cough
headache
intermittent positive pressure ventilation
pharyngitis
gastrointestinal symptoms
malaise
myalgia
SARS
vasoconstrictor
critically ill
respiratory failure
sore throat
respiratory tract infection
coronavirus infection
fraction of inspired oxygen (fio2)
throat
acute respiratory syndrome (sars)

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