Overview

Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection

Status:
Completed
Trial end date:
2020-06-13
Target enrollment:
0
Participant gender:
All
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 well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sharp HealthCare
Treatments:
Angiotensin Receptor Antagonists
Losartan
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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