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Losartan for Patients With COVID-19 Not 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: NCT04311177
Recruitment Status : Completed
First Posted : March 17, 2020
Results First Posted : May 4, 2022
Last Update Posted : May 4, 2022
Sponsor:
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 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Losartan Placebo
Hide Arm/Group Description

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Period Title: Overall Study
Started 58 59
Completed 50 55
Not Completed 8 4
Reason Not Completed
Adverse Event             3             1
Physician Decision             4             3
Withdrawal by Subject             1             0
Arm/Group Title Losartan Placebo Total
Hide Arm/Group Description

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Total of all reporting groups
Overall Number of Baseline Participants 58 59 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 59 participants 117 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
  94.8%
59
 100.0%
114
  97.4%
>=65 years
3
   5.2%
0
   0.0%
3
   2.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 59 participants 117 participants
Female
33
  56.9%
25
  42.4%
58
  49.6%
Male
25
  43.1%
34
  57.6%
59
  50.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 59 participants 117 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.7%
5
   8.5%
6
   5.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.9%
4
   6.8%
8
   6.8%
White
45
  77.6%
40
  67.8%
85
  72.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
  13.8%
10
  16.9%
18
  15.4%
1.Primary Outcome
Title Percentage of Participants Admitted to the Hospital
Hide Description

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.

Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.2
(1.1 to 14.4)
1.7
(0.0 to 9.1)
2.Secondary Outcome
Title Change in PROMIS Dyspnea Scale
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 50 patients were analyzed for this outcome measure due to loss to follow-up or refusal to complete the survey resulting in data missingness.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.4  (0.9) -0.5  (0.7)
3.Secondary Outcome
Title Change in SF-12 Physical Composite Score
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 31 39
Mean (Standard Deviation)
Unit of Measure: score
1.4  (9.1) 0.2  (6.5)
4.Secondary Outcome
Title Change in SF-12 Mental Composite Score
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 31 39
Mean (Standard Deviation)
Unit of Measure: score
-0.1  (6.5) -0.3  (5.7)
5.Secondary Outcome
Title Daily Maximum Temperature
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Mean (Standard Error)
Unit of Measure: degrees Farenheit
97.7  (0.097) 97.8  (0.092)
6.Secondary Outcome
Title Count of Participants With an Emergency Department or Clinic Presentation
Hide Description Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Measure Type: Count of Participants
Unit of Measure: Participants
10
  17.2%
5
   8.5%
7.Secondary Outcome
Title Disease Severity Rating Day 15
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 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Mean (Standard Deviation)
Unit of Measure: score
5.8  (0.5) 5.9  (0.7)
8.Secondary Outcome
Title Change in Viral Load by Nasopharyngeal Swab at Day 9
Hide Description Viral load is measured as number of viral genetic copies per mL.
Time Frame 9 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 32 35
Mean (Standard Error)
Unit of Measure: log10 copies/mL
-3.8  (0.3) -3.6  (0.29)
9.Secondary Outcome
Title Change in Viral Load by Nasopharyngeal Swab at Day 15
Hide Description 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 Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 35 25
Mean (Standard Error)
Unit of Measure: log10 copies/mL
-3.7  (0.33) -4  (0.29)
10.Secondary Outcome
Title Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days
Hide Description Outcome reported as the percent of participants in each arm who require ICU admission by day 15 following randomization.
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.7
(0.0 to 9.2)
1.7
(0.0 to 9.1)
11.Secondary Outcome
Title Need for Oxygen Therapy at 15 Days
Hide Description Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

Overall Number of Participants Analyzed 58 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.7
(0.0 to 9.2)
1.7
(0.0 to 9.1)
Time Frame 28 days
Adverse Event Reporting Description Events were monitored / assessed without regard to specific adverse event term, but rather by systems.
 
Arm/Group Title Losartan Placebo
Hide Arm/Group Description

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

Losartan: Losartan; 25 mg daily; oral administration

Participants in this arm will receive a placebo treatment.

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

All-Cause Mortality
Losartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)      0/59 (0.00%)    
Hide Serious Adverse Events
Losartan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/58 (5.17%)      1/59 (1.69%)    
Respiratory, thoracic and mediastinal disorders     
Hospital Admission *  3/58 (5.17%)  3 1/59 (1.69%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Losartan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/58 (74.14%)      56/59 (94.92%)    
Cardiac disorders     
Cardiovascular *  9/58 (15.52%)  9 6/59 (10.17%)  6
Ear and labyrinth disorders     
Ear, Nose, and Throat *  7/58 (12.07%)  7 4/59 (6.78%)  4
Gastrointestinal disorders     
Gastrointestinal *  4/58 (6.90%)  4 4/59 (6.78%)  4
Nervous system disorders     
Neurologic *  3/58 (5.17%)  3 2/59 (3.39%)  2
Renal and urinary disorders     
Renal *  2/58 (3.45%)  2 5/59 (8.47%)  5
Respiratory, thoracic and mediastinal disorders     
Respiratory *  9/58 (15.52%)  9 22/59 (37.29%)  22
Skin and subcutaneous tissue disorders     
Skin *  3/58 (5.17%)  3 0/59 (0.00%)  0
Social circumstances     
Constitutional *  6/58 (10.34%)  6 13/59 (22.03%)  13
*
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04311177    
Other Study ID Numbers: SURG-2020-28683
First Submitted: March 13, 2020
First Posted: March 17, 2020
Results First Submitted: March 16, 2022
Results First Posted: May 4, 2022
Last Update Posted: May 4, 2022