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.
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 ratio will be 1:1. The goal of this study is to identify whether or not ARBs
have an impact on inhibiting the progression to respiratory failure requiring mechanical
ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The
addition of an ARB to the standard of care treatment for these patients may be beneficial in
abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.
Drug: Losartan
Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.
Other Name: Losartan + Standard of Care
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
Sharp Grossmont Hospital
La Mesa, California, United States
Sharp Chula Vista Medical Center
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Matthew Geriak, PharmD, Study Director
Sharp HealthCare