Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04340557|
Recruitment Status : Completed
First Posted : April 9, 2020
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
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|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV Infection||Drug: Losartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|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)|
|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|
|Actual Primary Completion Date :||June 13, 2020|
|Actual Study Completion Date :||June 13, 2020|
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.
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 Name: Losartan + Standard of Care
No Intervention: Group B (SOC)
Standard of Care
- 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
- 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
- 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
- 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
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|United States, California|
|Sharp Grossmont Hospital|
|La Mesa, California, United States, 91942|
|Sharp Chula Vista Medical Center|
|San Diego, California, United States, 91911|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|Study Director:||Matthew Geriak, PharmD||Sharp HealthCare|
Documents provided by Matthew Geriak, Sharp HealthCare:
|Responsible Party:||Matthew Geriak, Investigational Pharmacist, Sharp HealthCare|
|Other Study ID Numbers:||
2003902 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
|First Posted:||April 9, 2020 Key Record Dates|
|Results First Posted:||May 26, 2021|
|Last Update Posted:||May 26, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Angiotensin receptor blocker
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action