Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A (Study drug+SOC)
Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.
  • 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 names:
    • Losartan + Standard of Care
No Intervention
Group B (SOC)
Standard of Care

Recruiting Locations

More Details

NCT ID
NCT04340557
Status
Completed
Sponsor
Sharp HealthCare

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.