Losartan for Patients With COVID-19 Not Requiring Hospitalization

May 2, 2022 updated by: University of Minnesota

Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55415
        • Mayo Clinic Health System

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:

  • 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

Exclusion Criteria:

  • Randomization > 72 hours of meeting inclusion criteria
  • 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:

    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 (must be have been measured within 1 month of enrollment)
    4. 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:

    1. Cirrhosis
    2. History of hepatitis B or C
    3. Other liver disease that in the opinion of the investigator, would affect losartan clearance
    4. Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record)
  • Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment
  • Concurrent treatment with aliskiren
  • Inability to obtain informed consent
  • Enrollment in another blinded randomized clinical trial for COVID

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants in this arm will receive a placebo treatment.
Other: Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
EXPERIMENTAL: Losartan
Participants in this arm will receive the study drug, Losartan.
Drug: Losartan
Losartan; 25 mg daily; oral administration
Other Names:
  • Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Admitted to the Hospital
Time Frame: 15 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS Dyspnea Scale
Time Frame: 10 days
The PROMIS dyspnea scale consists of 4 subscales. 3 (1. general shortness of breath, 2. intensity, and 3. Frequency) are scored from 0 (no symptoms) to 10 (most severe). The 4th subscale is scored from 0-4 in response to the question "I've been short of breath" with 0 representing none and 4 the most severe, for a total range of 0-34. Results are difference between enrollment and day 10. There are no units.
10 days
Change in SF-12 Physical Composite Score
Time Frame: 10 days
The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
10 days
Change in SF-12 Mental Composite Score
Time Frame: 10 days
The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
10 days
Daily Maximum Temperature
Time Frame: 10 days
Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.
10 days
Count of Participants With an Emergency Department or Clinic Presentation
Time Frame: 28 days
Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.
28 days
Disease Severity Rating Day 15
Time Frame: 15 days
Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
15 days
Change in Viral Load by Nasopharyngeal Swab at Day 9
Time Frame: 9 days
Viral load is measured as number of viral genetic copies per mL.
9 days
Change in Viral Load by Nasopharyngeal Swab at Day 15
Time Frame: 15 days
Viral load is measured as number of viral genetic copies per mL.
15 days
Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days
Time Frame: 15 days
Outcome reported as the percent of participants in each arm who require ICU admission by day 15 following randomization.
15 days
Need for Oxygen Therapy at 15 Days
Time Frame: 15 days
Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.
15 days

Collaborators and Investigators

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

Sponsor

University of Minnesota

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)

April 9, 2020

Primary Completion (ACTUAL)

February 1, 2021

Study Completion (ACTUAL)

February 1, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (ACTUAL)

March 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURG-2020-28683

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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