Back to resultsDo Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Primary Purpose
SARS-CoV Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Losartan
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV Infection focused on measuring Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19
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
Sites / Locations
- Sharp Grossmont Hospital
- Sharp Chula Vista Medical Center
- Sharp Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A (Study drug+SOC)
Group B (SOC)
Arm Description
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.
Standard of Care
Outcomes
Primary Outcome Measures
Mechanical Ventilation
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Secondary Outcome Measures
ICU Transfer
Number of subjects transferred from non-ICU bed to an ICU bed
Oxygen Therapy
Mean number of liters of oxygen consumed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340557
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
June 13, 2020 (Actual)
Study Completion Date
June 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection
Keywords
Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Study drug+SOC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (SOC)
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Losartan + Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mechanical Ventilation
Description
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary Outcome Measure Information:
Title
ICU Transfer
Description
Number of subjects transferred from non-ICU bed to an ICU bed
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Title
Oxygen Therapy
Description
Mean number of liters of oxygen consumed
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Other Pre-specified Outcome Measures:
Title
Length of Hospital Stay
Description
Length of hospital stay from admission to discharge
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Title
In Hospital Mortality
Description
Number of subjects who expired while hospitalized
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Geriak, PharmD
Organizational Affiliation
Sharp HealthCare
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sharp Chula Vista Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33977506
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.
Results Reference
derived
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Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
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