Status:
COMPLETED
Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Jordana B. Cohen, MD, MSCE
Hanff, Thomas C., M.D., MPH
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 syndr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04338009
Start Date
March 31 2020
End Date
August 20 2020
Last Update
April 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104