COVID-19
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
Detailed description
Participants will be randomized in a 2:1 ratio of camostat:placebo. Approximately 300 participants are planned to be enrolled (200 participants to camostat mesilate and 100 participants to placebo). Participants will be treated with camostat mesilate 200 mg or placebo drug orally 4 times a day for 14 days, and receive local standard of care (SOC) in addition to study drug. Participants will be followed until Day 28. Participants will be seen in the clinic for assessments, blood draws, and mid-turbinate nasal samples on Screening/Day 1, Day 7, Day 15 and early termination.
Interventions
Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
DRUGPlacebo
Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Sponsors
Sagent Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults willing and able to provide informed consent before performing study procedures 2. Adults ≥18 years of age at time of informed consent 3. Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19 4. Have a mild or moderate form of COVID-19 defined as SpO2 \> 94% at screening 5. Participants must have at least 1 of the following risk factors for severe illness 1. Aged 65 years or older 2. Hypertension 3. Diabetes mellitus 4. Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis) 5. Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy 6. Severe obesity (body mass index \[BMI\] ≥ 40 kg/m\^2) 7. Chronic liver disease, including cirrhosis 6. Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28 7. If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug
Exclusion criteria
1. Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely 2. Known severe liver disease (eg, Child Pugh score \> 12, AST \>5 times upper limit) 3. SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio \< 300 mgHg 4. Known allergic reaction to camostat mesilate or one of its excipients 5. Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m\^2) or receiving dialysis 6. Pregnant or breastfeeding, or positive pregnancy test in a predose examination 7. Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed. 8. History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression at Day 28 | 28 days | Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Fever Resolution | Up to 28 days | Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28. |
| Resolution of Viral Shedding | Day 1, Day 7 and Day 15 | Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination. |
| Rate of Adverse Events and Serious Adverse Events | 28 days | Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28. |
| Cumulative Rate of Grade 3 and 4 Adverse Events | 28 days | Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28. |
| Rate of Discontinuation | 28 days | Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28). |
| Laboratory Parameter - Platelet Count | Day 1 and Day 15 | Clinical Laboratory Value of Platelet Count at Day 1 and Day 15 |
| Laboratory Parameter - Potassium Level | Day 1 and Day 15 | Clinical laboratory value of Potassium Levels at Day 1 and Day 15 |
| Survival Rate | Up to Day 15 and Day 28 | The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28). |
| Laboratory Parameter - Alanine Aminotransferase (ALT) | Day 1 and Day 15 | Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15 |
| Laboratory Parameter - Alkaline Phosphatase (ALP) | Day 1 and Day 15 | Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15 |
| Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Day 1 and Day 15 | Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15 |
| Vital Signs - Heart Rate | Day 1, Day 7 and Day 15 | Heart rate at Day 1, Day 7 and Day 15 |
| Vital Signs - Blood Pressure | Day 1, Day 7 and Day 15 | Blood pressure (BP) at Day 1, Day 7 and Day 15 |
| Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | Day 1, Day 7 and Day 15 | Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15 |
| Laboratory Parameter - Aspartate Aminotransferase (AST) | Day 1 and Day 15 | Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15 |
Countries
United States
Participant flow
Recruitment details
The study was performed between November 09, 2020 to March, 30 2021. Subjects were recruited from \ 25 sites across United States.
Participants by arm
| Arm | Count |
|---|---|
| Camostat Mesilate Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | 194 |
| Placebo Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. | 101 |
| Total | 295 |
Baseline characteristics
| Characteristic | Camostat Mesilate | Placebo | Total |
|---|---|---|---|
| Age, Customized < 55 years | 105 Participants | 53 Participants | 158 Participants |
| Age, Customized > or = 55 years | 89 Participants | 48 Participants | 137 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 115 Participants | 62 Participants | 177 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 39 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 17 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 153 Participants | 80 Participants | 233 Participants |
| Sex: Female, Male Female | 108 Participants | 61 Participants | 169 Participants |
| Sex: Female, Male Male | 86 Participants | 40 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 195 | 0 / 99 |
| other Total, other adverse events | 8 / 195 | 9 / 99 |
| serious Total, serious adverse events | 10 / 195 | 5 / 99 |
Outcome results
Primary
Disease Progression at Day 28
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
Time frame: 28 days
Population: The Intent-to-Treat population includes all subjects who were randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat Mesilate | Disease Progression at Day 28 | 10 Participants |
| Placebo | Disease Progression at Day 28 | 6 Participants |
p-value: 0.787Chi-squared
Secondary
Cumulative Rate of Grade 3 and 4 Adverse Events
Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Time frame: 28 days
Population: A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Camostat Mesilate | Cumulative Rate of Grade 3 and 4 Adverse Events | Grade 3 AEs | 6 Participants |
| Camostat Mesilate | Cumulative Rate of Grade 3 and 4 Adverse Events | Grade 4 AEs | 1 Participants |
| Placebo | Cumulative Rate of Grade 3 and 4 Adverse Events | Grade 3 AEs | 0 Participants |
| Placebo | Cumulative Rate of Grade 3 and 4 Adverse Events | Grade 4 AEs | 1 Participants |
Secondary
Laboratory Parameter - Alanine Aminotransferase (ALT)
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Alanine Aminotransferase (ALT) | Day 1 ALT | 30.2 U/L | Standard Deviation 27.58 |
| Camostat Mesilate | Laboratory Parameter - Alanine Aminotransferase (ALT) | Day 15 ALT | 27.9 U/L | Standard Deviation 20.1 |
| Placebo | Laboratory Parameter - Alanine Aminotransferase (ALT) | Day 1 ALT | 29.0 U/L | Standard Deviation 17.01 |
| Placebo | Laboratory Parameter - Alanine Aminotransferase (ALT) | Day 15 ALT | 27.9 U/L | Standard Deviation 22.28 |
Secondary
Laboratory Parameter - Alkaline Phosphatase (ALP)
Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Alkaline Phosphatase (ALP) | Day 1 ALP | 76.3 U/L | Standard Deviation 24.44 |
| Camostat Mesilate | Laboratory Parameter - Alkaline Phosphatase (ALP) | Day 15 ALP | 77.8 U/L | Standard Deviation 27.6 |
| Placebo | Laboratory Parameter - Alkaline Phosphatase (ALP) | Day 1 ALP | 80.5 U/L | Standard Deviation 25.55 |
| Placebo | Laboratory Parameter - Alkaline Phosphatase (ALP) | Day 15 ALP | 78.6 U/L | Standard Deviation 24.91 |
Secondary
Laboratory Parameter - Aspartate Aminotransferase (AST)
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Aspartate Aminotransferase (AST) | Day 1 AST | 24.6 U/L | Standard Deviation 14.71 |
| Camostat Mesilate | Laboratory Parameter - Aspartate Aminotransferase (AST) | Day 15 AST | 21.8 U/L | Standard Deviation 10.18 |
| Placebo | Laboratory Parameter - Aspartate Aminotransferase (AST) | Day 1 AST | 25.3 U/L | Standard Deviation 12.33 |
| Placebo | Laboratory Parameter - Aspartate Aminotransferase (AST) | Day 15 AST | 21.8 U/L | Standard Deviation 10.65 |
Secondary
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Day 1 GGT | 33.5 U/L | Standard Deviation 25.61 |
| Camostat Mesilate | Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Day 15 GGT | 34.1 U/L | Standard Deviation 30.5 |
| Placebo | Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Day 1 GGT | 33.4 U/L | Standard Deviation 29.91 |
| Placebo | Laboratory Parameter - Gamma-Glutamyl Transferase (GGT) | Day 15 GGT | 31.1 U/L | Standard Deviation 20.3 |
Secondary
Laboratory Parameter - Platelet Count
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Time frame: Day 1 and Day 15
Population: The Intent-to Treat Population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Platelet Count | Day 1 Platelet Count | 243 10^9 platelets/L | Standard Deviation 71.69 |
| Camostat Mesilate | Laboratory Parameter - Platelet Count | Day 15 Platelet Count | 288.3 10^9 platelets/L | Standard Deviation 86.66 |
| Placebo | Laboratory Parameter - Platelet Count | Day 1 Platelet Count | 252.1 10^9 platelets/L | Standard Deviation 80.45 |
| Placebo | Laboratory Parameter - Platelet Count | Day 15 Platelet Count | 281.5 10^9 platelets/L | Standard Deviation 83.22 |
Secondary
Laboratory Parameter - Potassium Level
Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Time frame: Day 1 and Day 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Laboratory Parameter - Potassium Level | Day 1 Potassium Level | 4.26 mmol/L | Standard Deviation 0.397 |
| Camostat Mesilate | Laboratory Parameter - Potassium Level | Day 15 Potassium Level | 4.30 mmol/L | Standard Deviation 0.363 |
| Placebo | Laboratory Parameter - Potassium Level | Day 1 Potassium Level | 4.23 mmol/L | Standard Deviation 0.391 |
| Placebo | Laboratory Parameter - Potassium Level | Day 15 Potassium Level | 4.29 mmol/L | Standard Deviation 0.407 |
Secondary
Rate of Adverse Events and Serious Adverse Events
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.
Time frame: 28 days
Population: A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Camostat Mesilate | Rate of Adverse Events and Serious Adverse Events | Treatment Emergent Adverse Event (TEAE) | 17 Participants |
| Camostat Mesilate | Rate of Adverse Events and Serious Adverse Events | Serious TEAEs | 10 Participants |
| Placebo | Rate of Adverse Events and Serious Adverse Events | Treatment Emergent Adverse Event (TEAE) | 13 Participants |
| Placebo | Rate of Adverse Events and Serious Adverse Events | Serious TEAEs | 5 Participants |
Secondary
Rate of Discontinuation
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Time frame: 28 days
Population: The Intent-to-Treat (ITT) population includes all subjects who were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat Mesilate | Rate of Discontinuation | 11 Participants |
| Placebo | Rate of Discontinuation | 5 Participants |
Secondary
Resolution of Viral Shedding
Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.
Time frame: Day 1, Day 7 and Day 15
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Camostat Mesilate | Resolution of Viral Shedding | No Viral Shedding at Day 1 | 32 Participants |
| Camostat Mesilate | Resolution of Viral Shedding | No Viral Shedding at Day 7 | 77 Participants |
| Camostat Mesilate | Resolution of Viral Shedding | No Viral Shedding at Day 15 | 136 Participants |
| Placebo | Resolution of Viral Shedding | No Viral Shedding at Day 1 | 25 Participants |
| Placebo | Resolution of Viral Shedding | No Viral Shedding at Day 7 | 36 Participants |
| Placebo | Resolution of Viral Shedding | No Viral Shedding at Day 15 | 65 Participants |
Secondary
Survival Rate
The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Time frame: Up to Day 15 and Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Camostat Mesilate | Survival Rate | Survival Status at Day 15 | 194 Participants |
| Camostat Mesilate | Survival Rate | Survival Status at Day 28 | 193 Participants |
| Placebo | Survival Rate | Survival Status at Day 15 | 101 Participants |
| Placebo | Survival Rate | Survival Status at Day 28 | 101 Participants |
Secondary
Time to Fever Resolution
Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.
Time frame: Up to 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Camostat Mesilate | Time to Fever Resolution | 3 Days |
| Placebo | Time to Fever Resolution | 1 Days |
Secondary
Vital Signs - Blood Pressure
Blood pressure (BP) at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Vital Signs - Blood Pressure | Systolic BP Day 1 | 128.7 mmHg | Standard Deviation 13.87 |
| Camostat Mesilate | Vital Signs - Blood Pressure | Systolic BP Day 7 | 128.2 mmHg | Standard Deviation 16.61 |
| Camostat Mesilate | Vital Signs - Blood Pressure | Systolic BP Day 15 | 128.1 mmHg | Standard Deviation 16.61 |
| Camostat Mesilate | Vital Signs - Blood Pressure | Diastolic BP Day 1 | 80.7 mmHg | Standard Deviation 8.9 |
| Camostat Mesilate | Vital Signs - Blood Pressure | Diastolic BP Day 7 | 80.2 mmHg | Standard Deviation 9.34 |
| Camostat Mesilate | Vital Signs - Blood Pressure | Diastolic BP Day 15 | 78.9 mmHg | Standard Deviation 8.72 |
| Placebo | Vital Signs - Blood Pressure | Diastolic BP Day 7 | 80.9 mmHg | Standard Deviation 9.6 |
| Placebo | Vital Signs - Blood Pressure | Systolic BP Day 1 | 129.6 mmHg | Standard Deviation 13.97 |
| Placebo | Vital Signs - Blood Pressure | Diastolic BP Day 1 | 80.8 mmHg | Standard Deviation 7.43 |
| Placebo | Vital Signs - Blood Pressure | Systolic BP Day 7 | 129.2 mmHg | Standard Deviation 15.54 |
| Placebo | Vital Signs - Blood Pressure | Diastolic BP Day 15 | 81.3 mmHg | Standard Deviation 10.65 |
| Placebo | Vital Signs - Blood Pressure | Systolic BP Day 15 | 129.2 mmHg | Standard Deviation 15.54 |
Secondary
Vital Signs - Heart Rate
Heart rate at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Vital Signs - Heart Rate | Heart rate Day 1 | 81.2 Beats/Minute | Standard Deviation 10.25 |
| Camostat Mesilate | Vital Signs - Heart Rate | Heart rate Day 7 | 81.2 Beats/Minute | Standard Deviation 10.07 |
| Camostat Mesilate | Vital Signs - Heart Rate | Heart rate Day 15 | 79.8 Beats/Minute | Standard Deviation 10.16 |
| Placebo | Vital Signs - Heart Rate | Heart rate Day 1 | 80.1 Beats/Minute | Standard Deviation 10.48 |
| Placebo | Vital Signs - Heart Rate | Heart rate Day 7 | 80.5 Beats/Minute | Standard Deviation 9.09 |
| Placebo | Vital Signs - Heart Rate | Heart rate Day 15 | 79.2 Beats/Minute | Standard Deviation 9.94 |
Secondary
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15
Population: The Intent-to-Treat population includes all subjects who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camostat Mesilate | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 1 | 97.3 Percentage of SpO2 | Standard Deviation 1.33 |
| Camostat Mesilate | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 7 | 97.3 Percentage of SpO2 | Standard Deviation 1.78 |
| Camostat Mesilate | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 15 | 97.6 Percentage of SpO2 | Standard Deviation 1.46 |
| Placebo | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 1 | 97.4 Percentage of SpO2 | Standard Deviation 1.3 |
| Placebo | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 7 | 97.3 Percentage of SpO2 | Standard Deviation 1.43 |
| Placebo | Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2) | SpO2 Day 15 | 97.5 Percentage of SpO2 | Standard Deviation 2.22 |