Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019

NCT04338009 | Completed Results DMC

• 1 other identifier: 842810
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Hierarchical Composite Endpoint

  The primary endpoint of the trial will be a global rank based on patient outcomes according to four factors: (1) time to death, (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), (3) the number of days supported by renal replacement therapy or pressor/inotropic therapy, and (4) a modified sequential Organ Failure Assessment (SOFA) score. The modified SOFA score will include the cardiac, respiratory, renal and coagulation domains of the SOFA score. How to interpret the rank?: patients are ranked from worst to best outcomes, such that patients with bad outcomes are ranked at the top and patients who have the best outcomes are ranked at the bottom.

  Up to 28 days

Secondary Outcomes (4)

• All-Cause Death

  Up to 28 days

• Length of Hospital Stay

  Up to 28 days

• Length of ICU Stay, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation

  Up to 28 days

• AUC SOFA

  Up to 28 days

Other Outcomes (2)

• Intensive Care Unit Admission or Respiratory Failure Requiring Mechanical Ventilation.

  Up to 28 days

• Hypotension Requiring Vasopressors, Inotropes or Mechanical Hemodynamic Support

  Up to 28 days

Study Arms (2)

Discontinuation arm

EXPERIMENTAL

The randomized intervention will be the discontinuation of ACEI/ARBs

Other: Discontinuation of ARB/ACEI

Continuation arm

EXPERIMENTAL

The randomized intervention will be the continuation of ACEI/ARBs

Other: Continuation of ARB/ACEI

Interventions

Discontinuation of ARB/ACEI 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.

Discontinuation arm

Continuation of ARB/ACEI 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).

Continuation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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).
• Use of ACEI or ARB as an outpatient prior to hospital admission.

You may not qualify if:

• Systolic blood pressure \<100 mmHg.
• Systolic blood pressure \> 180 mmHg or \>160 if unable to substitute ACEIs/ARBs for another antihypertensive class, per the investigator's discretion.
• Diastolic blood pressure \> 110 mmHg
• 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).
• Serum K\>5.0 mEq/L on admission.
• Known pregnancy or breastfeeding.
• eGFR \<30 mL/min/1.73m2
• \>50% increase in creatinine (to a creatinine \>1.5 mg/dl) compared to most recent creatinine in the past six months, if available
• Urine protein-to-creatitine ratio \> 3 g/g or proteinuria \> 3 g/24-hours within the past year
• Ongoing treatment with aliskiren or sacubitril-valsartan.
• Inability to obtain informed consent from patient.
• Inability to read and write or lack of access to a smart phone, computer or tablet device at the time of evaluation.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Jordana B. Cohen, MD, MSCE: collaborator
• Hanff, Thomas C., M.D., MPH: collaborator
• University of Arizona: collaborator
• Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud: collaborator
• Hospital Nacional Edgardo Rebagliati Martins: collaborator
• Hospital Español de Mendoza: collaborator
• Stanford University: collaborator
• Ottawa Hospital Research Institute: collaborator
• Hospital Civil de Guadalajara: collaborator
• Universidad Catolica Argentina: collaborator
• Caja Nacional de Salud: collaborator
• Departamento de Medicina, Hospital Alberto Barton Thompson, Callao, Peru: collaborator
• Karolinska Institutet: collaborator
• University of Miami: collaborator
• Division of Cardiology, Department of Medicine, Hospital Español, Buenos Aires, Argentina: collaborator
• University of Michigan: collaborator
• Jesse Chittams, MS: collaborator
• Duke University: collaborator
• Vasquez, Charles R., M.D.: collaborator

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Limitations of the study include (1) small sample size; (2) we did not control participant ACEI or ARB dosing or other medication exposures during the trial; (3) Although outcome adjudicators were masked to the randomly assigned groups when determining clinical endpoints, providers caring for the patients were aware of the group the patient was assigned to. It is possible that the open-label nature of the study might have introduced information bias or influenced provider behavior.

Results Point of Contact

• Title: Dr. Jordana Cohen
• Organization: University of Pennsylvania

jco@pennmedicine.upenn.edu

215-662-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine at the Hospital of the University of Pennsylvania

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 8, 2020
• Study Start: March 31, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: April 9, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)