Aggrenox To Treat Acute Covid-19

Covid19 Clinical Trial

— ATTAC-19  

Official title:

A Randomized Controlled Trial to Evaluate the Outcomes With Aggrenox in Patients With SARS-CoV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410328
• Other study ID #: Pro2020001469
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: January 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 patients in each randomized arm), we will determine the efficacy of Aggrenox on clinical outcomes.

Hypotheses / Research Question(s) Compared to standard care, the addition of Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg), to standard care will result in improvement in the composite COVID ordinal scale at day 15. Additionally, combined Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), and standard care will reduce the need for ventilation, length of mechanical ventilation, hospital length of stay, ICU length of stay, decrease risk of thromboembolic complications and improve survival more than standard care alone in SARS-CoV-2 patients.

Research Design and Methods Randomized design. Participants will be randomized 1:1 to Aggrenox or standard treatment. Arm 1: Active Comparator: (Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally).

Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks + standard care.

Arm 2: Standard care Comparator: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.

The investigators will perform a randomized, 2-arm, open-label single-site pilot study to evaluate the effect of oral Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), on clinical outcomes in patients with SARS-CoV-2. In this research proposal, investigators will randomly assign 132 consenting participants with diagnosis of SARS-CoV-2 to two treatment groups: 1) Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) + standard care and 2) standard care alone. Participants will be screened, enrolled, receive treatment and followed for 28 days. The study aim and procedure will be explained to every eligible subject and informed consent will be obtained from interested subjects or authorized proxy to participate in the study. The investigators will collect demographic, clinical, laboratory and radiological data. The patients would be followed daily for 2 weeks after enrollment while the patient is in the hospital and once discharged, they will be called every 3rd day to follow up on the symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care
Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.

Other:
• Standard of care
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.

Locations

Country	Name	City	State
United States	Rutgers New Jersey Medical School University Hospital	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covid (Coronavirus Disease-19) Ordinal Scale	Change in composite COVID ordinal scale at day 15. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death.; COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.	15 days
Secondary	Mortality	All-cause mortality assessed on day 15.	15 days
Secondary	Mortality	All-cause mortality assessed on day 28.	28 days
Secondary	Supplemental Oxygen	Supplemental Oxygen-free days	28 days
Secondary	Invasive-ventilator	Invasive-ventilator-free days	28 days
Secondary	ICU stay	ICU-free days	28 days
Secondary	Hospital stay	Hospital-free days	28 days
Secondary	Inflammatory markers	Decrease in the markers D-dimer/ Ferritin/ C-reactive protein	15 days
Secondary	Thromboembolic complications	Thromboembolic complications including stroke	28 days
Secondary	COVID ordinal scale	COVID ordinal scale	28 days