Aggrenox To Treat Acute Covid-19 (ATTAC-19)
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ClinicalTrials.gov Identifier: NCT04410328 |
Recruitment Status :
Completed
First Posted : June 1, 2020
Last Update Posted : February 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care Other: Standard of care | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Arm 1: Aggrenox plus standard care. 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. Arm 2: Standard care. 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, the 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial to Evaluate the Outcomes With Aggrenox in Patients With SARS-CoV-2 Infection |
Actual Study Start Date : | October 21, 2020 |
Actual Primary Completion Date : | October 15, 2021 |
Actual Study Completion Date : | October 15, 2021 |

Arm | Intervention/treatment |
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Experimental: Participants receiving Dipyridamole and Aspirin
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
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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 Name: Aggrenox Other: Standard of care Participants will receive standard care starting on the day of enrollment for a total of 2 weeks. |
Participants receiving standard of care
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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Other: Standard of care
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks. |
- Covid (Coronavirus Disease-19) Ordinal Scale [ Time Frame: 15 days ]
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.
- Mortality [ Time Frame: 15 days ]All-cause mortality assessed on day 15.
- Mortality [ Time Frame: 28 days ]All-cause mortality assessed on day 28.
- Supplemental Oxygen [ Time Frame: 28 days ]Supplemental Oxygen-free days
- Invasive-ventilator [ Time Frame: 28 days ]Invasive-ventilator-free days
- ICU stay [ Time Frame: 28 days ]ICU-free days
- Hospital stay [ Time Frame: 28 days ]Hospital-free days
- Inflammatory markers [ Time Frame: 15 days ]Decrease in the markers D-dimer/ Ferritin/ C-reactive protein
- Thromboembolic complications [ Time Frame: 28 days ]Thromboembolic complications including stroke
- COVID ordinal scale [ Time Frame: 28 days ]COVID ordinal scale

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410328
United States, New Jersey | |
Rutgers New Jersey Medical School University Hospital | |
Newark, New Jersey, United States, 07103 |
Principal Investigator: | Amit Singla, MD | Rutgers University |
Documents provided by Amit Singla, MD, FAANS, Rutgers, The State University of New Jersey:
Other Publications:
Responsible Party: | Amit Singla, MD, FAANS, Assistant Professor, Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT04410328 |
Other Study ID Numbers: |
Pro2020001469 |
First Posted: | June 1, 2020 Key Record Dates |
Last Update Posted: | February 16, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 SARS-CoV Aggrenox Dipyridamole Aspirin |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Aspirin Dipyridamole Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Phosphodiesterase Inhibitors |