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

Study Overview
=================
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 SARS-CoV-2 induced hypoxia.

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

Conditions
-----------------
SARS-CoV Infection

Intervention / Treatment
-----------------
* Drug: Losartan


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Study drug+SOC)<br>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<br>* 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.<br>* Other names: Losartan + Standard of Care;|
| No Intervention: Group B (SOC)<br>Standard of Care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Ventilation | Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Transfer | Number of subjects transferred from non-ICU bed to an ICU bed | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | 
| Oxygen Therapy | Mean number of liters of oxygen consumed | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19