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Losartan for Patients With COVID-19 Requiring Hospitalization

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: NCT04312009
Recruitment Status : Completed
First Posted : March 17, 2020
Results First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Corona Virus Infection
Acute Respiratory Distress Syndrome
SARS-CoV Infection
Interventions Drug: Losartan
Other: Placebo
Enrollment 205
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Losartan
Hide Arm/Group Description

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Period Title: Overall Study
Started 104 101
Completed 102 100
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Placebo Losartan Total
Hide Arm/Group Description

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Total of all reporting groups
Overall Number of Baseline Participants 104 101 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
  76.9%
78
  77.2%
158
  77.1%
>=65 years
24
  23.1%
23
  22.8%
47
  22.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
Female
41
  39.4%
41
  40.6%
82
  40.0%
Male
63
  60.6%
60
  59.4%
123
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.9%
7
   6.9%
9
   4.4%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   0.5%
Black or African American
30
  28.8%
37
  36.6%
67
  32.7%
White
47
  45.2%
35
  34.7%
82
  40.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
24
  23.1%
22
  21.8%
46
  22.4%
1.Primary Outcome
Title Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days
Hide Description Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: ratio
281.4
(256.7 to 306.1)
260.9
(234.1 to 287.8)
2.Secondary Outcome
Title Daily Hypotensive Episodes
Hide Description Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: episodes per day
0.048
(0.018 to 0.1)
0.119
(0.065 to 0.191)
3.Secondary Outcome
Title Proportion of Participants Requiring Vasopressors for Hypotension
Hide Description Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Measure Type: Number
Unit of Measure: proportion of participants
0.106 0.198
4.Secondary Outcome
Title Proportion of Participants Experiencing Acute Kidney Injury
Hide Description

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:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.106
(0.056 to 0.174)
0.119
(0.065 to 0.191)
5.Secondary Outcome
Title Oxygen Saturation / Fractional Inhaled Oxygen (S/F)
Hide Description 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 S/F ratio is unitless.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: n/a (ratio)
357.4
(330.3 to 384.5)
331.5
(302.0 to 361.0)
6.Secondary Outcome
Title 28-Day Mortality
Hide Description Outcome reported as the number of participants who have expired at 28 days post enrollment.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 104 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.087
(0.031 to 0.139)
0.11
(0.047 to 0.169)
7.Secondary Outcome
Title 90-Day Mortality
Hide Description Outcome reported as the number of participants who have expired at 90 days post enrollment.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 104 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.106
(0.045 to 0.163)
0.11
(0.047 to 0.169)
8.Secondary Outcome
Title ICU Admission
Hide Description Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.272
(0.192 to 0.363)
0.36
(0.270 to 0.457)
9.Secondary Outcome
Title Number of Ventilator-Free Days
Hide Description Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: days
18.4
(16.5 to 20.4)
18.1
(16.1 to 20.1)
10.Secondary Outcome
Title Number of Therapeutic Oxygen-Free Days
Hide Description Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: days
24.6
(23.1 to 26.1)
23.6
(21.8 to 25.3)
11.Secondary Outcome
Title Number of Vasopressor-Free Days
Hide Description Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: days
9.4
(9.1 to 9.8)
8.7
(8.2 to 9.3)
12.Secondary Outcome
Title Length of Hospital Stay
Hide Description Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 104 101
Median (95% Confidence Interval)
Unit of Measure: days
5.9
(4.2 to 7.9)
7.1
(5.2 to 9.1)
13.Secondary Outcome
Title Disease Severity Rating
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: score
4.3
(4.0 to 4.6)
4.2
(3.8 to 4.5)
14.Secondary Outcome
Title Change in Viral Load by Nasopharyngeal Swab Day 15
Hide Description Nasopharyngeal swabs will be collected at baseline and day 15. Viral load is measured as number of viral genetic copies per mL.
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Losartan
Hide Arm/Group Description:

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: log10 copies/mL
-4.2
(-5.2 to -3.1)
-4.8
(-5.6 to -3.9)
Time Frame 15 days
Adverse Event Reporting Description adverse events were assessed and compared by organ system and not by specific adverse event term
 
Arm/Group Title Placebo Losartan
Hide Arm/Group Description

Participants in this arm will receive a placebo treatment.

Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Participants in this arm will receive the study drug, Losartan.

Losartan: Losartan; 50 mg daily; oral administration

All-Cause Mortality
Placebo Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   11/104 (10.58%)      11/101 (10.89%)    
Hide Serious Adverse Events
Placebo Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/104 (28.85%)      36/101 (35.64%)    
Blood and lymphatic system disorders     
Hematologic *  0/104 (0.00%)  0 1/101 (0.99%)  1
Cardiac disorders     
Cardiovascular *  6/104 (5.77%)  6 14/101 (13.86%)  14
Gastrointestinal disorders     
Gastrointestinal *  0/104 (0.00%)  0 1/101 (0.99%)  1
Nervous system disorders     
Neurologic *  1/104 (0.96%)  1 2/101 (1.98%)  2
Renal and urinary disorders     
Renal *  2/104 (1.92%)  2 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory *  21/104 (20.19%)  21 19/101 (18.81%)  19
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/104 (86.54%)      101/101 (100.00%)    
Blood and lymphatic system disorders     
Hematologic *  6/104 (5.77%)  6 9/101 (8.91%)  9
Cardiac disorders     
Cardiovascular *  24/104 (23.08%)  24 26/101 (25.74%)  26
Ear and labyrinth disorders     
Ear, Nose, and Throat *  1/104 (0.96%)  1 0/101 (0.00%)  0
Endocrine disorders     
Endocrine *  1/104 (0.96%)  1 2/101 (1.98%)  2
Gastrointestinal disorders     
Gastrointestinal *  3/104 (2.88%)  3 10/101 (9.90%)  10
Nervous system disorders     
Neurologic *  4/104 (3.85%)  4 4/101 (3.96%)  4
Renal and urinary disorders     
Genitourinary *  1/104 (0.96%)  1 3/101 (2.97%)  3
Renal *  21/104 (20.19%)  21 20/101 (19.80%)  20
Respiratory, thoracic and mediastinal disorders     
Respiratory *  27/104 (25.96%)  27 30/101 (29.70%)  30
Skin and subcutaneous tissue disorders     
Skin *  2/104 (1.92%)  2 0/101 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Tignanelli
Organization: University of Minnesota
Phone: 612-626-1968
EMail: ctignane@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04312009    
Other Study ID Numbers: SURG-2020-28675
INV-017069 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Submitted: March 13, 2020
First Posted: March 17, 2020
Results First Submitted: March 15, 2022
Results First Posted: June 29, 2022
Last Update Posted: June 29, 2022