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NCT04410328 · ClinicalTrials.gov registry record · Phase 3
Aggrenox To Treat Acute Covid-19
A Phase 3 study of COVID-19, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT04410328: Completed Phase 3 study of COVID-19, sponsored by Rutgers, The State University of New Jersey.
NCT04410328 is a Phase 3 study of COVID-19 that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 98 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410328, a Phase 3 study of COVID-19, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in composite COVID ordinal scale from day 1 to 14. 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)
Conditions Studied
Interventions
- OTHER Standard of care
- DRUG Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care
Study Locations (1)
New Jersey
- Rutgers New Jersey Medical School University Hospital - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2021-10-15 |
| Phase | Phase 3 |
What the finished NCT04410328 record still lists
NCT04410328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.
NCT04410328 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04410328 about?
NCT04410328 is a clinical study titled "Aggrenox To Treat Acute Covid-19". 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 or...
What is the current status of trial NCT04410328?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2020-10-21. Estimated completion is 2021-10-15.
What conditions does trial NCT04410328 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04410328?
The interventions under investigation include: Standard of care (OTHER), Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care (DRUG).
Who is sponsoring clinical trial NCT04410328?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04410328 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04410328's enrollment target sits among peer trials
98 205th of 298 higher than 93 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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