Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04410328
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2020-05-28
Brief Title:
Aggrenox To Treat Acute Covid-19
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate the Outcomes With Aggrenox in Patients With SARS-CoV-2 Infection
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATTAC-19
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 divided almost equally into 2 groups one group will receive Dipyridamole ER 200mg Aspirin 25mg orallyenterally 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
Detailed Description:
PurposeSpecific 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 Questions 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 orallyenterally 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 11 to Aggrenox or standard treatment Arm 1 Active Comparator Aggrenox Dipyridamole ER 200mg Aspirin 25mg orallyenterally
Participants will receive Aggrenox Dipyridamole ER 200mg Aspirin 25mg orallyenterally 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 orallyenterally 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 orallyenterally 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
Among 132 SARS-CoV-2 patients 66 patients in each randomized arm we will determine the efficacy of Aggrenox on clinical outcomes
Hypotheses Research Questions 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 orallyenterally 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 11 to Aggrenox or standard treatment Arm 1 Active Comparator Aggrenox Dipyridamole ER 200mg Aspirin 25mg orallyenterally
Participants will receive Aggrenox Dipyridamole ER 200mg Aspirin 25mg orallyenterally 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 orallyenterally 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 orallyenterally 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None