Status:
COMPLETED
Aggrenox To Treat Acute Covid-19
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Covid19
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. An anticipated total of 132 participants will be randomly...
Detailed Description
Purpose/Specific Aims: The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. Among 132 SARS-CoV-2 patients (66...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Hospitalization.
- SARS-CoV-2 viral nucleic acid positive within 3 days.
- Lab test result pending plus a high clinical suspicion for SARS-CoV-2 (fever and cough for ≤ 7 days, bilateral pulmonary infiltrates on imaging or new hypoxemia with spO2 ≤94% on room air or no alternative explanation for respiratory symptoms).
- Willing and able to provide consent or by authorized proxy.
Exclusion
- Pregnancy.
- G-6PD deficiency.
- Use of antiplatelet agents including inhibitor of P2Y12 ADP platelet receptors, phosphodiesterase inhibitors, and Glycoprotein IIB/IIIA inhibitors.
- On therapeutic anticoagulation with coumadin, heparin and direct oral anticoagulants.
- Vasodilatory shock.
- Patient with known ongoing angina, recent myocardial infarction and sub-valvular aortic stenosis.
- Active gastric or duodenal ulcer or any bleeding disorder.
- Hemoglobin \<9 mg/dL, platelet count of \<30,000 /mm3.
- Acute respiratory infection for \>10 days.
- Known allergy/hypersensitivity to Dipyridamole and/or Aspirin.
- Severe hepatic or renal insufficiency.
- Uncontrolled hypertension defined as systolic \> 180 mm Hg or diastolic \> 100 mm Hg.
- Patients with known allergy to NSAIDs
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04410328
Start Date
October 21 2020
End Date
October 15 2021
Last Update
February 21 2025
Active Locations (1)
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1
Rutgers New Jersey Medical School University Hospital
Newark, New Jersey, United States, 07103