Clinical trial NCT04340557: Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: SARS-CoV Infection
Keywords: Coronavirus
Angiotensin receptor blocker
SARS-CoV-2
COVID-19
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Mechanical Ventilation
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary outcomes:
measure: ICU Transfer
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
measure: Oxygen Therapy
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Other outcomes:
measure: Length of Hospital Stay
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
measure: In Hospital Mortality
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Locations:
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: Matthew Geriak, PharmD
role: STUDY_DIRECTOR
References:
citation: Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11.