Aggrenox To Treat Acute Covid-19

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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 divided almost equally into 2 groups: one group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and laboratory outcomes of all the participants enrolled in the study will be evaluated at the end of the study to explore if there is any difference in the outcomes between 2 groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: Boehringer Ingelheim
• Treatments: Aspirin; Dipyridamole

Criteria

Inclusion Criteria:

1. Age ≥18 years.

2. Hospitalization.

3. SARS-CoV-2 viral nucleic acid positive within 3 days.

4. 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).

5. Willing and able to provide consent or by authorized proxy.

Exclusion Criteria:

1. Pregnancy.

2. G-6PD deficiency.

3. Use of antiplatelet agents including inhibitor of P2Y12 ADP platelet receptors, phosphodiesterase inhibitors, and Glycoprotein IIB/IIIA inhibitors.

4. On therapeutic anticoagulation with coumadin, heparin and direct oral anticoagulants.

5. Vasodilatory shock.

6. Patient with known ongoing angina, recent myocardial infarction and sub-valvular aortic stenosis.

7. Active gastric or duodenal ulcer or any bleeding disorder.

8. Hemoglobin <9 mg/dL, platelet count of <30,000 /mm3.

9. Acute respiratory infection for >10 days.

10. Known allergy/hypersensitivity to Dipyridamole and/or Aspirin.

11. Severe hepatic or renal insufficiency.

12. Uncontrolled hypertension defined as systolic > 180 mm Hg or diastolic > 100 mm Hg.

13. Patients with known allergy to NSAIDs