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

May 24, 2021 updated by: Matthew Geriak, Sharp HealthCare

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Sharp Grossmont Hospital
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Diego, California, United States, 91911
        • Sharp Chula Vista Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group B (SOC)
Standard of Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Length of hospital stay from admission to discharge
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
In Hospital Mortality
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 who expired while hospitalized
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharp HealthCare

Investigators

  • Study Director: Matthew Geriak, PharmD, Sharp HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Actual)

June 13, 2020

Study Completion (Actual)

June 13, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-ARB
  • 2003902 (Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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