Losartan for Patients With COVID-19 Not Requiring Hospitalization
Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization
1 other identifier
interventional
117
1 country
4
Brief Summary
This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedResults Posted
Study results publicly available
May 4, 2022
CompletedMay 4, 2022
May 1, 2022
10 months
March 13, 2020
March 16, 2022
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Admitted to the Hospital
Outcome reported as the percentage of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.
15 days
Secondary Outcomes (10)
Change in PROMIS Dyspnea Scale
10 days
Change in SF-12 Physical Composite Score
10 days
Change in SF-12 Mental Composite Score
10 days
Daily Maximum Temperature
10 days
Count of Participants With an Emergency Department or Clinic Presentation
28 days
- +5 more secondary outcomes
Study Arms (2)
Losartan
EXPERIMENTALParticipants in this arm will receive the study drug, Losartan.
Placebo
PLACEBO COMPARATORParticipants in this arm will receive a placebo treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Positive laboratory test for COVID-19 based on local laboratory standard
- Age greater than or equal to 18 years of age
- One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (\>101.5) or loss of taste / smell
You may not qualify if:
- Randomization \> 7 days of symptom onset
- 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 women
- Females able to have children 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, condom use or abstinence during the study. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks.
- Patient reported history or electronic medical record history of kidney disease, defined as:
- Any history of dialysis
- History of chronic kidney disease stage IV
- Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 (must be have been measured within 1 month of enrollment)
- Other kidney disease that in the opinion of the investigator, would affect losartan clearance
- Patient reported dehydration and significantly decreased urine output in the past 72 hours
- Most recent systolic blood pressure prior to enrollment \<110 mmHg
- Patient reported history or electronic medical record history of severe liver disease, defined as:
- Cirrhosis
- History of hepatitis B or C
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Health System
Rochester, Minnesota, 55415, United States
Related Publications (2)
Puskarich MA, Cummins NW, Ingraham NE, Wacker DA, Reilkoff RA, Driver BE, Biros MH, Bellolio F, Chipman JG, Nelson AC, Beckman K, Langlois R, Bold T, Aliota MT, Schacker TW, Voelker HT, Murray TA, Koopmeiners JS, Tignanelli CJ. A multi-center phase II randomized clinical trial of losartan on symptomatic outpatients with COVID-19. EClinicalMedicine. 2021 Jun 17;37:100957. doi: 10.1016/j.eclinm.2021.100957. eCollection 2021 Jul.
PMID: 34195577RESULTSmolander J, Bruchfeld A. [COVID-19 and kidney disease]. Lakartidningen. 2020 Jul 13;117:20110. Swedish.
PMID: 32658300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Tignanelli
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Tignanelli, MD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Michael Puskarich, MD, MS
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2020
First Posted
March 17, 2020
Study Start
April 9, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
May 4, 2022
Results First Posted
May 4, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share