Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019
NCT ID: NCT04338009
Last Updated: 2021-04-09
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
152 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-31
Study Completion Date
2020-08-20
Brief Summary
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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.
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Detailed Description
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Conditions
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COVID-19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Discontinuation arm
The randomized intervention will be the discontinuation of ACEI/ARBs
Group Type
EXPERIMENTAL
Discontinuation of ARB/ACEI
Intervention Type
OTHER
The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.
Continuation arm
The randomized intervention will be the continuation of ACEI/ARBs
Group Type
EXPERIMENTAL
Continuation of ARB/ACEI
Intervention Type
OTHER
The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Interventions
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Discontinuation of ARB/ACEI
The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.
Intervention Type
OTHER
Continuation of ARB/ACEI
The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Age 18 years or older
2. Hospitalization with a suspected diagnosis of COVID-19, based on: (a) A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or (b) Considered by the primary team to be a Person Under Investigation due to undergo testing for COVID-19 in addition to compatible pulmonary infiltrates on chest x-ray (mutilobar, intersticial or ground glass opacities).
3. Use of ACEI or ARB as an outpatient prior to hospital admission.
2. Hospitalization with a suspected diagnosis of COVID-19, based on: (a) A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or (b) Considered by the primary team to be a Person Under Investigation due to undergo testing for COVID-19 in addition to compatible pulmonary infiltrates on chest x-ray (mutilobar, intersticial or ground glass opacities).
3. Use of ACEI or ARB as an outpatient prior to hospital admission.
Exclusion Criteria
1. Systolic blood pressure \<100 mmHg.
2. Systolic blood pressure \> 180 mmHg or \>160 if unable to substitute ACEIs/ARBs for another antihypertensive class, per the investigator's discretion.
3. Diastolic blood pressure \> 110 mmHg
4. Known history of heart failure with reduced ejection fraction (EF \<40%) on their most recent echo and/or clinical heart failure with unknown EF (i.e. no echo in approximately the past year).
5. Serum K\>5.0 mEq/L on admission.
6. Known pregnancy or breastfeeding.
7. eGFR \<30 mL/min/1.73m2
8. \>50% increase in creatinine (to a creatinine \>1.5 mg/dl) compared to most recent creatinine in the past six months, if available
9. Urine protein-to-creatitine ratio \> 3 g/g or proteinuria \> 3 g/24-hours within the past year
10. Ongoing treatment with aliskiren or sacubitril-valsartan.
11. Inability to obtain informed consent from patient.
12. Inability to read and write or lack of access to a smart phone, computer or tablet device at the time of evaluation.
2. Systolic blood pressure \> 180 mmHg or \>160 if unable to substitute ACEIs/ARBs for another antihypertensive class, per the investigator's discretion.
3. Diastolic blood pressure \> 110 mmHg
4. Known history of heart failure with reduced ejection fraction (EF \<40%) on their most recent echo and/or clinical heart failure with unknown EF (i.e. no echo in approximately the past year).
5. Serum K\>5.0 mEq/L on admission.
6. Known pregnancy or breastfeeding.
7. eGFR \<30 mL/min/1.73m2
8. \>50% increase in creatinine (to a creatinine \>1.5 mg/dl) compared to most recent creatinine in the past six months, if available
9. Urine protein-to-creatitine ratio \> 3 g/g or proteinuria \> 3 g/24-hours within the past year
10. Ongoing treatment with aliskiren or sacubitril-valsartan.
11. Inability to obtain informed consent from patient.
12. Inability to read and write or lack of access to a smart phone, computer or tablet device at the time of evaluation.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Jordana B. Cohen, MD, MSCE
UNKNOWN
Sponsor Role
collaborator
Hanff, Thomas C., M.D., MPH
INDIV
Sponsor Role
collaborator
University of Arizona
OTHER
Sponsor Role
collaborator
Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
OTHER
Sponsor Role
collaborator
Hospital Nacional Edgardo Rebagliati Martins
OTHER
Sponsor Role
collaborator
Hospital Español de Mendoza
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Ottawa Hospital Research Institute
OTHER
Sponsor Role
collaborator
Hospital Civil de Guadalajara
OTHER
Sponsor Role
collaborator
Universidad Catolica Argentina
OTHER
Sponsor Role
collaborator
Caja Nacional de Salud
OTHER
Sponsor Role
collaborator
Departamento de Medicina, Hospital Alberto Barton Thompson, Callao, Peru
OTHER
Sponsor Role
collaborator
Karolinska Institutet
OTHER
Sponsor Role
collaborator
University of Miami
OTHER
Sponsor Role
collaborator
Division of Cardiology, Department of Medicine, Hospital Español, Buenos Aires, Argentina
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
Jesse Chittams, MS
UNKNOWN
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
collaborator
Vasquez, Charles R., M.D.
INDIV
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
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Julio A. Chirinos
Associate Professor of Medicine at the Hospital of the University of Pennsylvania
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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842810
Identifier Type: -
Identifier Source: org_study_id
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