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

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ClinicalTrials.gov Identifier: NCT04340557
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Geriak, Sharp HealthCare

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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Drug: Losartan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
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.

No Intervention: Group B (SOC)
Standard of Care



Primary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure


Secondary Outcome Measures :
  1. ICU transfer [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of subjects transferred from non-ICU bed to an ICU bed

  2. Oxygen therapy [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of days requiring oxygen therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340557


Contacts
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Contact: Katie Miller (858) 939-7162 kathryn.miller@sharp.com
Contact: Cary Murphy, RN (619)740-4363 cary.murphy@sharp.com

Locations
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United States, California
Sharp Grossmont Hospital Recruiting
La Mesa, California, United States, 91942
Contact: Cary Murphy, RN    619-740-4363    cary.murphy@sharp.com   
Contact: Adriana Valdez-Hernandez, RN    (619)458-2260    Adriana.Valdez-hernandez@sharp.com   
Sharp Chula Vista Medical Center Recruiting
San Diego, California, United States, 91911
Contact: Cary Murphy, RN    619-740-4363    cary.murphy@sharp.com   
Contact: Adriana Valdez-Hernandez, RN    (619)458-2260    Adriana.Valdez-hernandez@sharp.com   
Sharp Coronado Hospital Recruiting
San Diego, California, United States, 92118
Contact: Cary Murphy, RN    619-740-4363    Cary.Murphy@sharp.com   
Contact: Adriana Valdez-Hernandez, RN    (619)458-2260    Adriana.Valdez-hernandez@sharp.com   
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Matthew Geriak, PharmD    858-939-3717    matthew.geriak@sharp.com   
Contact: Cary Murphy, RN    (619) 740-4363    cary.murphy@sharp.com   
Sponsors and Collaborators
Sharp HealthCare
Investigators
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Study Director: George Sakoulas, MD Sharp HealthCare
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Responsible Party: Matthew Geriak, Investigational Pharmacist, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04340557    
Other Study ID Numbers: COVID-ARB
2003902 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Matthew Geriak, Sharp HealthCare:
Coronavirus
Angiotensin receptor blocker
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action