Status:
TERMINATED
Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19
Lead Sponsor:
UConn Health
Conditions:
COVID-19 Pneumonia
Vascular Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The original protocol stipulated an enrollment of 100 patients, randomized in a 1 to 1 distribution of treatment versus control \[placebo\] group. However, the study was terminated because of insuffic...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
Key Trial Info
Start Date :
May 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04424901
Start Date
May 3 2020
End Date
April 24 2022
Last Update
April 21 2023
Active Locations (1)
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1
UConn Health
Farmington, Connecticut, United States, 06030