Official Title
Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
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 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.

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 SARSCoV-2 induced hypoxia.

Recruiting
SARS-CoV Infection

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.
Group A (Study drug+SOC)

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Sharp Grossmont Hospital
La Mesa, California, 91942

Recruiting

Investigator: Cary Murphy, RN
Contact: 619-740-4363
cary.murphy@sharp.com


Investigator: Adriana Valdez-Hernandez, RN
Contact: (619)458-2260
Adriana.Valdez-hernandez@sharp.com

Sharp Chula Vista Medical Center
San Diego, California, 91911

Recruiting

Investigator: Cary Murphy, RN
Contact: 619-740-4363
cary.murphy@sharp.com


Investigator: Adriana Valdez-Hernandez, RN
Contact: (619)458-2260
Adriana.Valdez-hernandez@sharp.com

Sharp Coronado Hospital
San Diego, California, 92118

Recruiting

Investigator: Cary Murphy, RN
Contact: 619-740-4363
Cary.Murphy@sharp.com


Investigator: Adriana Valdez-Hernandez, RN
Contact: (619)458-2260
Adriana.Valdez-hernandez@sharp.com

Sharp Memorial Hospital
San Diego, California, 92123

Recruiting

Investigator: Matthew Geriak, PharmD
Contact: 858-939-3717
matthew.geriak@sharp.com


Investigator: Cary Murphy, RN
Contact: (619) 740-4363
cary.murphy@sharp.com

Contacts

Katie Miller
(858) 939-7162
kathryn.miller@sharp.com

Cary Murphy, RN
(619)740-4363
cary.murphy@sharp.com

George Sakoulas, MD
Study Director
Sharp HealthCare

Sharp HealthCare
NCT Number
Keywords
Coronavirus
Angiotensin receptor blocker
SARS-CoV-2
Covid-19
MeSH Terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Losartan