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NCT04365699 · ClinicalTrials.gov registry record · Phase 2
Cardiovascular Effects of COVID-19
A Phase 2 study of COVID-19, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT04365699: Completed Phase 2 study of COVID-19, sponsored by NYU Langone Health.
NCT04365699 is a Phase 2 study of COVID-19 that has completed, run by NYU Langone Health. The registered enrollment target is 81 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
NCT04365699, a Phase 2 study of COVID-19, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic patients with COVID-19. An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14 days. Safety, tolerability, survival and length of hospital stay data were compared with matched controls from a contemporaneous registry of COVID-19 patients.
Primary Outcome
Data collection from medical chart review
Conditions Studied
Interventions
- DRUG AT-001
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2021-01-31 |
| Phase | Phase 2 |
What the finished NCT04365699 record still lists
NCT04365699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 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 1 intervention - of which AT-001 is the first listed.
NCT04365699 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04365699 about?
NCT04365699 is a clinical study titled "Cardiovascular Effects of COVID-19". Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic ...
What is the current status of trial NCT04365699?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2020-04-08. Estimated completion is 2021-01-31.
What conditions does trial NCT04365699 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04365699?
The interventions under investigation include: AT-001 (DRUG).
Who is sponsoring clinical trial NCT04365699?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04365699 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04365699's enrollment target sits among peer trials
81 215th of 298 higher than 84 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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