Losartan for Patients With COVID-19 Requiring Hospitalization
NCT ID: NCT04312009
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
205 participants
INTERVENTIONAL
2020-04-13
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Losartan
Participants in this arm will receive the study drug, Losartan.
Losartan
Losartan; 50 mg daily; oral administration
Placebo
Participants in this arm will receive a placebo treatment.
Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Interventions
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Losartan
Losartan; 50 mg daily; oral administration
Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years of age
* Admission to the hospital with a respiratory SOFA \>=1 and increased oxygen requirement compared to baseline among those on home O2
* Randomization within 48 hours of presentation of hospital admission or within 48 hours of a positive test result, whichever is later
Exclusion Criteria
* Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
* Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema
* Pregnant or breastfeeding
* Lack of negative urine or serum pregnancy test
* Not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate / Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study period; use of condoms or agree to abstain from sexual intercourse during the study. All women of child bearing age enrolled in this fashion will be informed of the teratogenic risks. If enrolled under LAR, they will be informed of the risks after regaining capacity.
* Patient reported history or electronic medical record history of kidney disease, defined as:
1. Any history of dialysis
2. History of chronic kidney disease stage IV
3. Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at the time of randomization
* Severe dehydration at the time of enrollment in the opinion of the investigator or bedside clinician
* Most recent mean arterial blood pressure prior to enrollment \<65 mmHg
* Patient reported history or electronic medical record history of severe liver disease, defined as:
1. Cirrhosis
2. History of hepatitis B or C
3. Documented AST or ALT \> 3 times the upper limit of normal measured within 24 hours prior to randomization
* Potassium \>5.0 within 24 hours prior to randomization unless a repeat value was \<=5.0
* Treatment with aliskiren
* Inability to obtain informed consent from participant or legally authorized representative
* Enrollment in another blinded randomized clinical trial for COVID
18 Years
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Christopher Tignanelli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Michael Puskarich, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Florida Health Gainesville
Gainesville, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
North Memorial Health Hospital
Robbinsdale, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cooper University Hospital
Camden, New Jersey, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Puskarich MA, Ingraham NE, Merck LH, Driver BE, Wacker DA, Black LP, Jones AE, Fletcher CV, South AM, Murray TA, Lewandowski C, Farhat J, Benoit JL, Biros MH, Cherabuddi K, Chipman JG, Schacker TW, Guirgis FW, Voelker HT, Koopmeiners JS, Tignanelli CJ; Angiotensin Receptor Blocker Based Lung Protective Strategies for Inpatients With COVID-19 (ALPS-IP) Investigators. Efficacy of Losartan in Hospitalized Patients With COVID-19-Induced Lung Injury: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222735. doi: 10.1001/jamanetworkopen.2022.2735.
Smolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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INV-017069
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SURG-2020-28675
Identifier Type: -
Identifier Source: org_study_id
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