Trial Outcomes & Findings for A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19) (NCT NCT04504032)
NCT ID: NCT04504032
Last Updated: 2021-10-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
497 participants
Primary outcome timeframe
Up to Day 35
Results posted on
2021-10-22
Participant Flow
A total of 538 participants were screened of which only 497 were randomized to treatment.
Participant milestones
| Measure |
Rivaroxaban
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
251
|
|
Overall Study
COMPLETED
|
210
|
223
|
|
Overall Study
NOT COMPLETED
|
36
|
28
|
Reasons for withdrawal
| Measure |
Rivaroxaban
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Study terminated by sponsor
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
Disease progression prior to dosing
|
15
|
3
|
|
Overall Study
Drug supply issues
|
1
|
1
|
|
Overall Study
Progressed to moderate/severe COVID-19
|
1
|
0
|
Baseline Characteristics
A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=246 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=251 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
Total
n=497 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.28 • n=113 Participants
|
48.6 years
STANDARD_DEVIATION 12.14 • n=163 Participants
|
49.2 years
STANDARD_DEVIATION 12.21 • n=160 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=113 Participants
|
159 Participants
n=163 Participants
|
299 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=113 Participants
|
92 Participants
n=163 Participants
|
198 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=113 Participants
|
46 Participants
n=163 Participants
|
95 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=113 Participants
|
201 Participants
n=163 Participants
|
398 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
36 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
White
|
219 Participants
n=113 Participants
|
222 Participants
n=163 Participants
|
441 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
14 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Up to Day 35Population: 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.
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.
Outcome measures
| Measure |
Rivaroxaban
n=219 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=230 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35
|
6 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to Day 35Population: Safety Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=219 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=230 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 35Population: Safety Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=219 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=230 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events Through Day 35
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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.
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28
|
46 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
Rivaroxaban
n=132 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=122 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28
|
21.0 Days
Interval 19.0 to 23.0
|
23.0 Days
Interval 20.0 to 27.0
|
SECONDARY outcome
Timeframe: Up to Day 28Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
Rivaroxaban
n=125 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=115 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28
|
23.0 Days
Interval 21.0 to 26.0
|
26.0 Days
Interval 22.0 to 28.0
|
SECONDARY outcome
Timeframe: Days 8, 14, and 21Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
36 Participants
|
|
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
|
40 Participants
|
|
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
|
42 Participants
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
Day 8
|
26 Participants
|
30 Participants
|
|
Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
Day 14
|
64 Participants
|
59 Participants
|
|
Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
Day 21
|
100 Participants
|
93 Participants
|
|
Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
Day 28
|
132 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
44 Participants
|
|
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
|
83 Participants
|
|
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
|
115 Participants
|
|
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
|
20 Participants
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
31 Participants
|
|
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
|
159 Participants
|
|
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
|
8 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
55 Participants
|
|
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
|
132 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
79 Participants
|
|
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
|
109 Participants
|
|
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
|
5 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
108 Participants
|
|
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
|
81 Participants
|
|
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
|
4 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
19 Participants
|
|
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
|
12 Participants
|
|
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
|
166 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
40 Participants
|
|
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
|
16 Participants
|
|
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
|
137 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
72 Participants
|
|
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
|
8 Participants
|
|
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
|
112 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
106 Participants
|
|
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
|
4 Participants
|
|
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
|
82 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population
Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
Up to Day 8
|
3 Participants
|
6 Participants
|
|
Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
Up to Day 14
|
3 Participants
|
7 Participants
|
|
Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
Up to Day 21
|
3 Participants
|
7 Participants
|
|
Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
Up to Day 28
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Median Number of Days of Hospitalization Through Day 35
|
5.0 Days
Interval 4.0 to 5.0
|
4.0 Days
Interval 2.0 to 30.0
|
SECONDARY outcome
Timeframe: Days 8, 14, 21, and 28Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
17 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
106 Participants
|
|
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
|
81 Participants
|
|
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
|
4 Participants
|
|
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
|
0 Participants
|
|
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
|
9 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
30 Participants
|
|
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
|
158 Participants
|
|
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
|
8 Participants
|
|
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
|
0 Participants
|
|
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
|
4 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
54 Participants
|
|
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
|
131 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
8 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
78 Participants
|
|
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
|
109 Participants
|
|
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
|
5 Participants
|
|
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
|
0 Participants
|
|
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
|
8 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Days 8, 14, 21, and 28Population: ITT Population
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.
Outcome measures
| Measure |
Rivaroxaban
n=222 Participants
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=222 Participants
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
18 Participants
|
|
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
|
12 Participants
|
|
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
|
166 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
39 Participants
|
|
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
|
16 Participants
|
|
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
|
137 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
72 Participants
|
|
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
|
8 Participants
|
|
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
|
112 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
105 Participants
|
|
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
|
4 Participants
|
|
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
|
82 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
12 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Days 8, 14, 21, and 28Gates 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Days 8, 14, 21, and 28The 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.
Outcome measures
Outcome data not reported
Adverse Events
Rivaroxaban
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban
n=219 participants at risk
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=230 participants at risk
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/219 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.43%
1/230 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.91%
2/219 • Number of events 2 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
1.7%
4/230 • Number of events 4 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute kidney injury
|
0.00%
0/219 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.43%
1/230 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/219 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.43%
1/230 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/219 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.43%
1/230 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
Other adverse events
| Measure |
Rivaroxaban
n=219 participants at risk
Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
|
Placebo
n=230 participants at risk
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
4/219 • Number of events 4 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.00%
0/230 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Infections and infestations
COVID -19/COVID-19 pneumonia/pneumonia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
2.2%
5/230 • Number of events 5 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Nervous system disorders
Headache
|
1.4%
3/219 • Number of events 3 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
1.7%
4/230 • Number of events 4 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
3/219 • Number of events 3 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
0.00%
0/230 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.46%
1/219 • Number of events 1 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
1.3%
3/230 • Number of events 3 • Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER