Losartan for Patients With COVID-19 Requiring Hospitalization

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT04312009
• Collaborator: Bill and Melinda Gates Foundation (Other)
• Enrollment: 205
• Locations: 13
• Arms: 2
• Actual Duration (Months): 9.7
• Patients Per Site: 15.8
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection; Acute Respiratory Distress Syndrome; SARS-CoV Infection	Drug: Losartan; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
• Actual Study Start Date: Apr 13, 2020
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Losartan Participants in this arm will receive the study drug, Losartan.	Drug: Losartan; Losartan; 50 mg daily; oral administration; Other Names: Cozaar
Placebo Comparator: Placebo Participants in this arm will receive a placebo treatment.	Other: Placebo; Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Outcome Measures

Primary Outcome Measures

1. Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days [7 days]

   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.

Secondary Outcome Measures

1. Daily Hypotensive Episodes [10 days]

   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.

2. Proportion of Participants Requiring Vasopressors for Hypotension [10 days]

   Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

3. Proportion of Participants Experiencing Acute Kidney Injury [10 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: 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.

4. Oxygen Saturation / Fractional Inhaled Oxygen (S/F) [7 days]

   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.

5. 28-Day Mortality [28 days]

   Outcome reported as the number of participants who have expired at 28 days post enrollment.

6. 90-Day Mortality [90 days]

   Outcome reported as the number of participants who have expired at 90 days post enrollment.

7. ICU Admission [10 days]

   Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

8. Number of Ventilator-Free Days [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.

9. Number of Therapeutic Oxygen-Free Days [28 days]

   Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

10. Number of Vasopressor-Free Days [10 days]

    Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

11. Length of Hospital Stay [90 days]

    Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

12. Disease Severity Rating [28 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.

13. Change in Viral Load by Nasopharyngeal Swab Day 15 [15 days]

    Nasopharyngeal swabs will be collected at baseline and day 15. Viral load is measured as number of viral genetic copies per mL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Presumptive positive laboratory test for Covid-19 based on local laboratory standard

• Age greater than or equal to 18 years of age

• Admission to the hospital with a respiratory SOFA >=1 and increased oxygen requirement compared to baseline among those on home O2

• Randomization within 48 hours of presentation of hospital admission or within 48 hours of a positive test result, whichever is later

Exclusion Criteria:

• Randomization > 48 hours of admission order or positive test result, whichever is later

• 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

• Lack of negative urine or serum pregnancy test

• 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 period; use of condoms or agree to abstain from sexual intercourse during the study. All women of child bearing age enrolled in this fashion will be informed of the teratogenic risks. If enrolled under LAR, they will be informed of the risks after regaining capacity.

• 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 at the time of randomization

• Severe dehydration at the time of enrollment in the opinion of the investigator or bedside clinician

• Most recent mean arterial blood pressure prior to enrollment <65 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. Documented AST or ALT > 3 times the upper limit of normal measured within 24 hours prior to randomization

• Potassium >5.0 within 24 hours prior to randomization unless a repeat value was <=5.0

• Treatment with aliskiren

• Inability to obtain informed consent from participant or legally authorized representative

• Enrollment in another blinded randomized clinical trial for COVID

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Health Gainesville	Gainesville	Florida	United States	32611
2	University of Florida Health Jacksonville	Jacksonville	Florida	United States	32209
3	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
4	Henry Ford Hospital	Detroit	Michigan	United States	48202
5	M Health Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
6	M Health Fairview Southdale Hospital	Edina	Minnesota	United States	55435
7	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
8	M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455
9	University of Minnesota	Minneapolis	Minnesota	United States	55455
10	North Memorial Health Hospital	Robbinsdale	Minnesota	United States	55422
11	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
12	Cooper University Hospital	Camden	New Jersey	United States	08103
13	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of Minnesota
• Bill and Melinda Gates Foundation

Investigators

• Principal Investigator: Christopher Tignanelli, MD, University of Minnesota
• Principal Investigator: Michael Puskarich, MD, MS, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 22, 2020
• Informed Consent Form - Apr 2, 2020

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04312009
• Other Study ID Numbers: SURG-2020-28675; INV-017069
• First Posted: Mar 17, 2020
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by University of Minnesota: COVID-19; Corona Virus; SARS-COV-2
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Losartan

Study Results

Participant Flow

Arm/Group Title	Placebo	Losartan
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

Baseline Characteristics

Arm/Group Title	Placebo	Losartan	Total
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 Participants	104	101	205
Age (Count of Participants)
<=18 years	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 (Count of Participants)
Female	41 39.4%	41 40.6%	82 40%
Male	63 60.6%	60 59.4%	123 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%	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%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	24 23.1%	22 21.8%	46 22.4%

Outcome Measures

1. Primary Outcome

Title	Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [ratio]	281.4	260.9

2. Secondary Outcome

Title	Daily Hypotensive Episodes
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [episodes per day]	0.048	0.119

3. Secondary Outcome

Title	Proportion of Participants Requiring Vasopressors for Hypotension
Description	Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Number [proportion of participants]	0.106 0.1%	0.198 0.2%

4. Secondary Outcome

Title	Proportion of Participants Experiencing Acute Kidney Injury
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Number (95% Confidence Interval) [proportion of participants]	0.106 0.1%	0.119 0.1%

5. Secondary Outcome

Title	Oxygen Saturation / Fractional Inhaled Oxygen (S/F)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [n/a (ratio)]	357.4	331.5

6. Secondary Outcome

Title	28-Day Mortality
Description	Outcome reported as the number of participants who have expired at 28 days post enrollment.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	104	101
Number (95% Confidence Interval) [proportion of participants]	0.087 0.1%	0.11 0.1%

7. Secondary Outcome

Title	90-Day Mortality
Description	Outcome reported as the number of participants who have expired at 90 days post enrollment.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	104	101
Number (95% Confidence Interval) [proportion of participants]	0.106 0.1%	0.11 0.1%

8. Secondary Outcome

Title	ICU Admission
Description	Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Number (95% Confidence Interval) [proportion of participants]	0.272 0.3%	0.36 0.4%

9. Secondary Outcome

Title	Number of Ventilator-Free Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [days]	18.4	18.1

10. Secondary Outcome

Title	Number of Therapeutic Oxygen-Free Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [days]	24.6	23.6

11. Secondary Outcome

Title	Number of Vasopressor-Free Days
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [days]	9.4	8.7

12. Secondary Outcome

Title	Length of Hospital Stay
Description	Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	104	101
Median (95% Confidence Interval) [days]	5.9	7.1

13. Secondary Outcome

Title	Disease Severity Rating
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [score]	4.3	4.2

14. Secondary Outcome

Title	Change in Viral Load by Nasopharyngeal Swab Day 15
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Losartan
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
Measure Participants	102	100
Mean (95% Confidence Interval) [log10 copies/mL]	-4.2	-4.8

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	11/104 (10.6%)		11/101 (10.9%)
Serious Adverse Events
	Placebo		Losartan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/104 (28.8%)		36/101 (35.6%)
Blood and lymphatic system disorders
Hematologic	0/104 (0%)	0	1/101 (1%)	1
Cardiac disorders
Cardiovascular	6/104 (5.8%)	6	14/101 (13.9%)	14
Gastrointestinal disorders
Gastrointestinal	0/104 (0%)	0	1/101 (1%)	1
Nervous system disorders
Neurologic	1/104 (1%)	1	2/101 (2%)	2
Renal and urinary disorders
Renal	2/104 (1.9%)	2	1/101 (1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory	21/104 (20.2%)	21	19/101 (18.8%)	19
Other (Not Including Serious) Adverse Events
	Placebo		Losartan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/104 (86.5%)		101/101 (100%)
Blood and lymphatic system disorders
Hematologic	6/104 (5.8%)	6	9/101 (8.9%)	9
Cardiac disorders
Cardiovascular	24/104 (23.1%)	24	26/101 (25.7%)	26
Ear and labyrinth disorders
Ear, Nose, and Throat	1/104 (1%)	1	0/101 (0%)	0
Endocrine disorders
Endocrine	1/104 (1%)	1	2/101 (2%)	2
Gastrointestinal disorders
Gastrointestinal	3/104 (2.9%)	3	10/101 (9.9%)	10
Nervous system disorders
Neurologic	4/104 (3.8%)	4	4/101 (4%)	4
Renal and urinary disorders
Genitourinary	1/104 (1%)	1	3/101 (3%)	3
Renal	21/104 (20.2%)	21	20/101 (19.8%)	20
Respiratory, thoracic and mediastinal disorders
Respiratory	27/104 (26%)	27	30/101 (29.7%)	30
Skin and subcutaneous tissue disorders
Skin	2/104 (1.9%)	2	0/101 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.