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History of Changes for Study: NCT04312009
Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Latest version (submitted June 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 13, 2020 None (earliest Version on record)
2 March 19, 2020 Oversight, Study Identification and Study Status
3 April 1, 2020 Study Status and Contacts/Locations
4 April 15, 2020 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Eligibility and Arms and Interventions
5 April 21, 2020 Contacts/Locations and Study Status
6 April 29, 2020 Sponsor/Collaborators and Study Status
7 May 7, 2020 Study Status and Study Identification
8 June 3, 2020 Study Status and Contacts/Locations
9 June 11, 2020 Eligibility and Study Status
10 June 30, 2020 Contacts/Locations and Study Status
11 July 17, 2020 Contacts/Locations and Study Status
12 December 2, 2020 Study Status and Contacts/Locations
13 December 17, 2020 Outcome Measures and Study Status
14 February 12, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 April 8, 2021 Outcome Measures and Study Status
16 August 16, 2021 Study Status and Study Design
17 March 15, 2022
Quality Control Review has not concluded Returned: April 7, 2022
Outcome Measures, Study Status, Document Section
18 April 22, 2022
Quality Control Review has not concluded Returned: May 2, 2022
Adverse Events, Outcome Measures, Study Status
19 May 2, 2022
Quality Control Review has not concluded Returned: May 4, 2022
Outcome Measures, Study Status
20 May 4, 2022
Quality Control Review has not concluded Returned: May 27, 2022
Outcome Measures and Study Status
21 June 20, 2022
Quality Control Review has not concluded Returned: June 27, 2022
Study Status, Outcome Measures
22 June 27, 2022 Study Status, Outcome Measures
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Study NCT04312009
Submitted Date:  March 13, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: SURG-2020-28675-I
Brief Title: Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Official Title: Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: March 16, 2020
Primary Completion: April 1, 2021 [Anticipated]
Study Completion: April 1, 2021 [Anticipated]
First Submitted: March 13, 2020
First Submitted that
Met QC Criteria:
March 13, 2020
First Posted: March 17, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 13, 2020
Last Update Posted: March 17, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Minnesota
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
Detailed Description:
Open or close this module Conditions
Conditions: Corona Virus Infection
Acute Respiratory Distress Syndrome
SARS-CoV Infection
Keywords: COVID-19
Corona Virus
SARS-COV-2
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Losartan
Participants in this arm will receive the study drug, Losartan.
Drug: Losartan
Losartan; 25 mg daily; oral administration
Other Names:
  • Cozaar
Placebo Comparator: Placebo
Participants in this arm will receive a placebo treatment.
Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Sequential Organ Failure Assessment (SOFA) Respiratory Score
[ Time Frame: 28 days ]

The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).

Outcome is reported as only the respiratory component score. Respiratory scores range from 0-4, with higher scores indicating greater chance of mortality due to respiratory failure.

Secondary Outcome Measures:
1. 28-Day Mortality
[ Time Frame: 28 days ]

Outcome reported as the number of participants who have expired at 28 days post enrollment.
2. 90-Day Mortality
[ Time Frame: 90 days ]

Outcome reported as the number of participants who have expired at 90 days post enrollment.
3. Respiratory Failure Requiring Mechanical Ventilation
[ Time Frame: 7 days ]

Outcome reported as the number of participants receiving in-patient hospital care requiring mechanical ventilation due to respiratory failure.
4. Number of 28-Day Ventilator-Free Days
[ Time Frame: 28 days ]

Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
5. Length of Hospital Stay
[ Time Frame: approximately 28 days ]

Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
6. ICU Admission
[ Time Frame: approximately 28 days ]

Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
7. ICU Length of Stay
[ Time Frame: approximately 28 days ]

Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
8. Acute Kidney Injury
[ Time Frame: approximately 28 days ]

Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

  1. Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
  2. Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
  3. Urine output less than 0.5 mL/kg/h for 6 hours.
9. Hypotension Requiring Vasopressors
[ Time Frame: approximately 28 days ]

Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
10. Sequential Organ Failure Assessment (SOFA) Total Score
[ Time Frame: approximately 14 days ]

The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
11. Severity Assessment
[ 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.
12. Incidence of Respiratory Failure
[ Time Frame: approximately 28 days ]

Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
13. Oxygen Saturation / Fractional Inhaled Oxygen (F/S)
[ Time Frame: 72 hours ]

Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Presumptive positive laboratory test for SARS-CoV-2 or upper respiratory infection with recent exposure to laboratory-proven SARS-CoV-2-infected person
  • Negative influenza and respiratory virus panel
  • New or worsening hypoxia (SpO2 <95%) compared to baseline or increasing oxygen requirement
  • Randomization within 24 hours of initial presentation to a hospital (inclusive of transfer)

Exclusion Criteria:

  • Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
  • Prior reaction or intolerance to an ARB or ACEi
  • Blood pressure less than 110/70 mmHg
  • Potassium great than 5.0 mEq/L within 4 weeks of study enrollment.
  • Pregnancy or breastfeeding
  • In females of childbearing age, unwillingness to use birth control for the duration of the study
  • Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation or history of advanced renal disease
  • AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment
  • Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of Losartan
  • Concurrent treatment with Alikirin
  • Inability to obtain informed consent
  • Non-English speakers
Open or close this module Contacts/Locations
Central Contact Person: Christopher Tignanelli, MD
Telephone: 612-625-7911
Email: ctignane@umn.edu
Central Contact Backup: Michael Puskarich, MD, MS
Telephone: 612-626-6911
Email: mike-em@umn.edu
Study Officials: Christopher Tignanelli, MD
Principal Investigator
University of Minnesota
Michael Puskarich, MD, MS
Principal Investigator
University of Minnesota
Locations: United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Contact:Sub-Investigator: Jeffrey Chipman, MD
Contact:Sub-Investigator: Ron Reikoff, MD
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact:Sub-Investigator: Timothy Schacker, MD
Contact:Sub-Investigator: Nicholas Ingraham, MD
Contact:Sub-Investigator: David Wacker, MD
Contact:Sub-Investigator: Michelle Biros, MD, MS
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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