COVID-19
Conditions
Keywords
Rivaroxaban, Xarelto, Coronavirus, COVID-19, Coronavirus disease 2019
Brief summary
The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.
Interventions
DRUGRivaroxaban
Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
DRUGPlacebo
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
Sponsors
Gates Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be at high-risk for Coronavirus disease 2019 (COVID-19) disease progression by fulfilling at least one of the following criteria at screening: * Presence of chronic pulmonary disease, chronic obstructive pulmonary disease (COPD), pulmonary hypertension * Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment * Hypertension, requiring at least one oral medication for treatment * Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a cluster of differentiation 4 \[CD4\] T-cell count of \<200 per cubic millimeter \[mm\^3\]) * Immunocompromised status due to medication (e.g., taking 20 milligram \[mg\] or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, cancer therapies) * Any chronic disease that is associated with high risk for severe COVID in the opinion of the site investigator * Body mass index ≥35 Kilogram per square meter (kg/m\^2) (based on self-reported weight and height). * Documented Severe Acute Respiratory Syndrome Coronavirus 2 positive diagnostic test of ≤7 days at the time of screening * Symptomatic for COVID-19 for ≤72 hours at the time of screening (defined as having at least 2 of the following symptoms of COVID-19 that is of new onset or has worsened from baseline, and include fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, anosmia, ageusia, nausea, vomiting, or diarrhea. If only two symptoms are present, they cannot both be anosmia and ageusia) * Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the inform consent form and in this protocol * Agree to participate in all remote, in-person or home visits as required in the protocol and provide updated contact information as necessary. * Female of childbearing potential must agree to practice adequate contraception during the study
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Currently hospitalized or under immediate consideration for hospitalization at screening and Day 1 * Have new onset shortness of breath or increased shortness of breath from pre-COVID-19 (for people with known COPD) at screening and Day 1 * Hypoxemia (oxygen saturation \<94% in ambient air or oxygen saturation below pre-COVID-19 level for people with known COPD) at Day 1 * Require supplemental oxygen (new requirement or increase in requirement from pre-COVID-19 condition) at screening and Day 1 * Have a history of (in the past 3 months) or current active pathological bleeding * Have a history of hemorrhagic stroke or intracranial hemorrhage * Have a recent severe head trauma within 30 days which includes concussion, skull fracture or hospitalization for head injury * Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or aneurysm * Have history of pregnancy-related hemorrhage * Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the past 3 months * Currently are in a hemodynamically unstable state * Currently require thrombolysis or pulmonary embolectomy * Have history of severe hypersensitivity reaction to Xarelto® * Currently have a prosthetic heart valve * Have known diagnosis of triple positive antiphospholipid syndrome * Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis) * Have a history of thrombocytopenia or known platelet count \<100,000 cells/mm\^3 * Have history of bronchiectasis and pulmonary cavitation * Have active cancer (e.g, receiving chemotherapy or treatment for complication of the active cancer) * Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks and plan to undergo these procedures during the study * Had surgery in the past 4 weeks or plan to undergo surgery during the study * Currently is pregnant or plans to become pregnant * Currently is breastfeeding * Share household with an enrolled participant in this study * Co-enrollment in any clinical trial that includes prohibited procedures (spinal puncture or surgery) or that includes treatments within the same drug class as rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited. Note that any co-enrollment other than this requires approval by the Sponsor. For any co-enrolled study, the total volume of blood samples collected across the studies should not exceed 275 milliliters (mL) in 4 weeks. * Currently using and plan to use the following medications during the study * Rivaroxaban or drugs in the same class * Dual anti-platelets therapy * Other anticoagulants * Combined Permeability glycoprotein (P-gp) and cytochrome P450 3A (CYP3A) inhibitors and inducers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Up to Day 28 | Participants who progressed to a moderate or severe disease category or higher (Bill & Melinda Gates Medical Research Institute \[Gates MRI\] ordinal scale ≥3) are reported. Gates MRI scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with Extra-Corporeal Membrane Oxygenation (ECMO); 7=Death. |
| Number of Participants With Serious Adverse Events Through Day 35 | Up to Day 35 | A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes. |
| Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Up to Day 35 | An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of a new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. AE severity was graded as Grade 3 (Severe) and Grade 4 (Potentially Life-threatening) per the specific toxicity grading by the Division of Acquired Immunodeficiency Syndrome (DAIDS) AE Grading Table. |
| Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Up to Day 35 | An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. |
| Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Viral clearance is defined as two consecutive negative diagnostic tests. Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. |
| Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Baseline; Days 8, 14, 21, and 28 | The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead. BS= Baseline; PBS= Post-Baseline; NA= Data not available. |
| Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead. |
| Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. |
| Median Number of Days of Hospitalization Through Day 35 | Up to Day 35 | Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. Hospitalized participants without an end date of hospitalization were not included. |
| Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. BS= Baseline; PBS= Post-Baseline; NA= Data not available. |
| Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. |
| Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | Up to Day 28 | Time to disease resolution is defined as the time from the first dose to the date of symptoms resolution (new-onset Coronavirus Disease 2019 \[COVID-19\] symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% confidence interval (CI) for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. |
| Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28 | Up to Day 28 | Time to disease resolution is defined as the time from the first dose to the date of both viral clearance (two consecutive negative diagnostic tests) and symptoms resolution (new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% CI for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. |
| Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Days 8, 14, and 21 | Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Baseline; Days 8, 14, 21, and 28 | The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 16. |
| Change From Baseline in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Baseline; Days 8, 14, 21, and 28 | Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre- COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 14. |
Countries
United Kingdom, United States
Participant flow
Pre-assignment details
A total of 538 participants were screened of which only 497 were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Rivaroxaban Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days. | 246 |
| Placebo Participants self-administered rivaroxaban matching placebo orally once daily for 21 days. | 251 |
| Total | 497 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Disease progression prior to dosing | 15 | 3 |
| Overall Study | Drug supply issues | 1 | 1 |
| Overall Study | Lost to Follow-up | 6 | 9 |
| Overall Study | Progressed to moderate/severe COVID-19 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Study terminated by sponsor | 1 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 11 |
Baseline characteristics
| Characteristic | Rivaroxaban | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 12.28 | 49.2 years STANDARD_DEVIATION 12.21 | 48.6 years STANDARD_DEVIATION 12.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants | 95 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 197 Participants | 398 Participants | 201 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 36 Participants | 19 Participants |
| Race/Ethnicity, Customized Mixed race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 14 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 219 Participants | 441 Participants | 222 Participants |
| Sex: Female, Male Female | 140 Participants | 299 Participants | 159 Participants |
| Sex: Female, Male Male | 106 Participants | 198 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 219 | 0 / 230 |
| other Total, other adverse events | 12 / 219 | 11 / 230 |
| serious Total, serious adverse events | 2 / 219 | 7 / 230 |
Outcome results
Primary
Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28
Participants who progressed to a moderate or severe disease category or higher (Bill & Melinda Gates Medical Research Institute \[Gates MRI\] ordinal scale ≥3) are reported. Gates MRI scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with Extra-Corporeal Membrane Oxygenation (ECMO); 7=Death.
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) Population: All participants assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rivaroxaban | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | 46 Participants |
| Placebo | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | 44 Participants |
Primary
Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35
An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions.
Time frame: Up to Day 35
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rivaroxaban | Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | 4 Participants |
| Placebo | Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | 5 Participants |
Primary
Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35
An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of a new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. AE severity was graded as Grade 3 (Severe) and Grade 4 (Potentially Life-threatening) per the specific toxicity grading by the Division of Acquired Immunodeficiency Syndrome (DAIDS) AE Grading Table.
Time frame: Up to Day 35
Population: Safety Population: all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rivaroxaban | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | 6 Participants |
| Placebo | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | 13 Participants |
Primary
Number of Participants With Serious Adverse Events Through Day 35
A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes.
Time frame: Up to Day 35
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rivaroxaban | Number of Participants With Serious Adverse Events Through Day 35 | 2 Participants |
| Placebo | Number of Participants With Serious Adverse Events Through Day 35 | 7 Participants |
Secondary
Median Number of Days of Hospitalization Through Day 35
Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. Hospitalized participants without an end date of hospitalization were not included.
Time frame: Up to Day 35
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rivaroxaban | Median Number of Days of Hospitalization Through Day 35 | 5.0 Days |
| Placebo | Median Number of Days of Hospitalization Through Day 35 | 4.0 Days |
Secondary
Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28
Time to disease resolution is defined as the time from the first dose to the date of symptoms resolution (new-onset Coronavirus Disease 2019 \[COVID-19\] symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% confidence interval (CI) for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates.
Time frame: Up to Day 28
Population: ITT Population. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rivaroxaban | Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | 21.0 Days |
| Placebo | Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | 23.0 Days |
Secondary
Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28
Time to disease resolution is defined as the time from the first dose to the date of both viral clearance (two consecutive negative diagnostic tests) and symptoms resolution (new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% CI for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates.
Time frame: Up to Day 28
Population: ITT Population. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rivaroxaban | Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28 | 23.0 Days |
| Placebo | Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28 | 26.0 Days |
Secondary
Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 8 | 26 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 14 | 64 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 21 | 100 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 28 | 132 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 28 | 122 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 8 | 30 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 21 | 93 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Day 14 | 59 Participants |
Secondary
Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28
Viral clearance is defined as two consecutive negative diagnostic tests. Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 8 | 12 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 14 | 49 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 21 | 86 Participants |
| Rivaroxaban | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 28 | 125 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 28 | 115 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 8 | 20 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 21 | 83 Participants |
| Placebo | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Day 14 | 44 Participants |
Secondary
Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21
Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death.
Time frame: Days 8, 14, and 21
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rivaroxaban | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 14 | 44 Participants |
| Rivaroxaban | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 8 | 38 Participants |
| Rivaroxaban | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 21 | 45 Participants |
| Placebo | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 8 | 36 Participants |
| Placebo | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 14 | 40 Participants |
| Placebo | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Day 21 | 42 Participants |
Secondary
Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rivaroxaban | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 8 | 3 Participants |
| Rivaroxaban | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 14 | 3 Participants |
| Rivaroxaban | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 21 | 3 Participants |
| Rivaroxaban | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 28 | 3 Participants |
| Placebo | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 28 | 7 Participants |
| Placebo | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 8 | 6 Participants |
| Placebo | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 21 | 7 Participants |
| Placebo | Number of Participants With Hospitalization Through Days 8, 14, 21, and 28 | Up to Day 14 | 7 Participants |
Secondary
Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28
Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population. Only those participants with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 1 | 98 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 2 | 87 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 3 | 3 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 3 | 1 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 2 | 114 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 1 | 69 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 3 | 3 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 1 | 125 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 2 | 57 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 3 | 1 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 2 | 152 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 1 | 33 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 1 | 55 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 1 | 31 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 2 | 159 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 3 | 8 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 2 | 132 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 3 | 7 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 1 | 79 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 2 | 109 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 3 | 5 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 1 | 108 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 2 | 81 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 3 | 4 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 4 | 0 Participants |
Secondary
Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28
The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population. Only those participants with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 10 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 10 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 9 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 1 | 14 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 2 | 154 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 3 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 4 | 1 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 8 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 9 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 10 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 0 | 56 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 1 | 15 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 2 | 115 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 3 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 8 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 9 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 0 | 87 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 1 | 12 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 2 | 87 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 3 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 8 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 0 | 19 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 0 | 117 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 1 | 9 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 2 | 57 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 3 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 4 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 5 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 6 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 7 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 8 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 9 | 0 Participants |
| Rivaroxaban | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 10 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 9 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 10 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 8 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 0 | 106 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 0 | 19 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 0 | 72 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 1 | 12 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 1 | 4 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 2 | 166 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 1 | 8 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 3 | 1 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 2 | 112 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 2 | 82 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 3 | 1 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 10 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 8 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 9 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 3 | 1 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 8 | Score 10 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 0 | 40 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 1 | 16 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 2 | 137 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 3 | 1 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 4 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 8 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 5 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 9 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 6 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 28 | Score 9 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 7 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 21 | Score 10 | 0 Participants |
| Placebo | Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28 | Day 14 | Score 8 | 0 Participants |
Secondary
Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28
Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. BS= Baseline; PBS= Post-Baseline; NA= Data not available.
Time frame: Days 8, 14, 21, and 28
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 3 | 3 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score NA | 12 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 1 | 2 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 1 | 2 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 1 | 96 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 2 | 87 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 3 | 1 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 1 | 31 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score NA | 9 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 2 | 152 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score NA | 12 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 3 | 3 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 1 | 67 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 1 | 2 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 2 | 114 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score NA | 12 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score NA | 7 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 1 | 123 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score NA | 9 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 2 | 57 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 3 | 1 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score NA | 12 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 1 | 2 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score NA | 12 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score >=4 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 1 | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 1 | 78 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 1 | 30 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 2 | 158 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 3 | 8 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score NA | 4 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score NA | 3 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 1 | 54 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 2 | 131 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 3 | 7 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score NA | 8 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 2 | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score NA | 3 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score NA | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 2 | 109 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 3 | 5 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score NA | 8 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 1 | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score NA | 3 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 1 | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 1 | 106 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 2 | 81 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 3 | 4 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score NA | 9 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 1 | 1 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score NA | 3 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score >=4 | 0 Participants |
| Placebo | Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 1 | 1 Participants |
Secondary
Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28
The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead. BS= Baseline; PBS= Post-Baseline; NA= Data not available.
Time frame: Baseline; Days 8, 14, 21, and 28
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 4 | 1 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score NA | 18 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 0 | 85 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 1 | 12 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 2 | 87 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score NA | 20 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 0 | 54 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score NA | 1 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 1 | 15 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 2 | 115 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 0 | 2 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score NA | 20 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score NA | 1 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score NA | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 0 | 115 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 1 | 9 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 2 | 57 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 0 | 17 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 2 | 154 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score NA | 23 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score NA | 1 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 1 | 14 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score NA | 1 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 0 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score >=6 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 0 | 2 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 1 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 2 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score NA | 15 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 0 | 2 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 3 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 0 | 2 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 4 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 5 | 0 Participants |
| Rivaroxaban | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 1 | 4 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 0 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 0 | 18 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 1 | 12 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 2 | 166 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 3 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 2 to PBS score NA | 7 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 3 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 0 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 0 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 0 | 39 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 1 | 16 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 2 | 137 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 3 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 2 to PBS score NA | 11 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score 3 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 14: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 0 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 1 to PBS score NA | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 0 | 72 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 1 | 8 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 2 | 112 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 3 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 2 to PBS score NA | 11 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score 3 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 21: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 0 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 1 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 0 | 105 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 2 | 82 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 0 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 3 | 1 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 2 to PBS score NA | 12 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score 3 to PBS score NA | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 1 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score 5 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score >=6 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 28: shift from BS score NA to PBS score NA | 17 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 0 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 2 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 4 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 3 | 0 Participants |
| Placebo | Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28 | Day 8: shift from BS score 0 to PBS score 1 | 0 Participants |
Other Pre-specified
Change From Baseline in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28
Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre- COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 14.
Time frame: Baseline; Days 8, 14, 21, and 28
Other Pre-specified
Change From Baseline in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28
The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 \<150 (SpO2/FiO2 \<200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 \<150 and vasopressors, dialysis, or ECMO; 10=Dead. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 16.
Time frame: Baseline; Days 8, 14, 21, and 28