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NCT04338009 · ClinicalTrials.gov registry record · NA
Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019
A NA study of COVID-19, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT04338009 is a NA study of COVID-19 that has completed, run by University of Pennsylvania. The registered enrollment target is 152 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04338009, a NA study of COVID-19, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Hypertension and cardiovascular disease are risk factors for death in COVID-19. Angiotensin converting enzyme 2 (ACE2), an important component of the renin-angiotensin system, serves as the binding site of SARS-CoV-2 and facilitates host cell entry in the lungs. In experimental models, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to increase ACE2 expression in several organs, potentially promoting viral cell invasion, although these findings are not consistent across studies. Alternatively, ACEIs and ARBs may actually improve mechanisms of host defense or hyperinflammation, ultimately reducing organ injury. Finally, ACEIs and ARBs may have direct renal, pulmonary and cardiac protective benefits in the setting of COVID-19. Therefore, it is unclear if ACEIs and ARBs may be beneficial or harmful in patients with COVID-19. Given the high prevalence of hypertension, cardiovascular and renal disease in the world, the high prevalence of ACEIs or ARBs in these conditions, and the clinical equipoise regarding the continuation vs. discontinuation of ACEIs/ARBs in the setting of COVID, a randomized trial is urgently needed. The aim of this trial is to assess the clinical impact of continuation vs. discontinuation of ACE inhibitors and angiotensin receptor blockers on outcomes in patients hospitalized with COVID-19.
Conditions Studied
Interventions
- OTHER Discontinuation of ARB/ACEI
- OTHER Continuation of ARB/ACEI
Study Locations (1)
Pennsylvania
- University of Pennsylvania Health System - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2020-08-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04338009
The ClinicalTrials.gov registry entry for NCT04338009 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Discontinuation of ARB/ACEI is the first listed.
NCT04338009 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04338009 about?
NCT04338009 is a clinical study titled "Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019". The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Hypertension and cardiovascular disease are risk factors for death in COVID-19...
What is the current status of trial NCT04338009?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2020-03-31. Estimated completion is 2020-08-20.
What conditions does trial NCT04338009 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04338009?
The interventions under investigation include: Discontinuation of ARB/ACEI (OTHER), Continuation of ARB/ACEI (OTHER).
Who is sponsoring clinical trial NCT04338009?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04338009 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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