Status:
COMPLETED
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Lead Sponsor:
Sharp HealthCare
Conditions:
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as...
Detailed Description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization rati...
Eligibility Criteria
Inclusion
- Confirmed COVID-19 positive test result
- Mild to moderate respiratory symptoms of COVID-19.
- Systolic blood pressure ≥ 105 mmHg.
- Screen within 3 days of a positive COVID-19 test.
- Age ≥18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls.
- Able to read/write/speak English or Spanish fluently.
- Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent.
- Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.
Exclusion
- Severe allergy to any ARB or ACE-inhibitor, including angioedema
- In the intensive care unit at screening.
- Home meds include any kind of ACE inhibitor or ARB
- Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)
- Hyperkalemia \>5.0 mmol/L at baseline or any time during treatment in the study treatment arm
- Creatinine Clearance \< 30 ml/min at baseline or any time during treatment in the study treatment arm
Key Trial Info
Start Date :
March 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04340557
Start Date
March 27 2020
End Date
June 13 2020
Last Update
May 26 2021
Active Locations (3)
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1
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
2
Sharp Chula Vista Medical Center
San Diego, California, United States, 91911
3
Sharp Memorial Hospital
San Diego, California, United States, 92123