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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005395-35 | EudraCT Number |
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Based on Data Monitoring Committee''s recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 35 |
| 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. | Up to Day 35 |
| 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. | Up to Day 35 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| GatesMRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland Research Northwest LLC - ERG - PPDS | Rogers | Arkansas | 72758 | United States | ||
| Science 37, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37591523 | Derived | Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2. | |
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
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A total of 538 participants were screened of which only 497 were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban | Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days. |
| FG001 | Placebo | Participants self-administered rivaroxaban matching placebo orally once daily for 21 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2021 | Sep 29, 2021 |
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| Placebo | Drug | Participants self-administered rivaroxaban matching placebo orally once daily for 21 days. |
|
| Up to Day 28 |
| Up to Day 28 |
| 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. | Up to Day 28 |
| 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. | Days 8, 14, and 21 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Up to Day 35 |
| 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. | Days 8, 14, 21, and 28 |
| 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. | Baseline; Days 8, 14, 21, and 28 |
| Baseline; Days 8, 14, 21, and 28 |
| 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. | Baseline; Days 8, 14, 21, and 28 |
| Los Angeles |
| California |
| 90094 |
| United States |
| Allergy and Asthma Medical Group and Research Center - CRN - PPDS | San Diego | California | 92123 | United States |
| Invesclinic, LLC | Fort Lauderdale | Florida | 33308 | United States |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | United States |
| LCC Medical Research - Miami - BTC - PPDS | Miami | Florida | 33126 | United States |
| Adult Medicine of Lake County | Mt. Dora | Florida | 32757 | United States |
| Providea Health Partners LLC | Evergreen Park | Illinois | 60805 | United States |
| Clinical Research Institute, Inc - CRN - PPDS | Minneapolis | Minnesota | 55402 | United States |
| Encompass Care | North Las Vegas | Nevada | 89086 | United States |
| Riverside Medical Group - Circuit- PPDS | Secaucus | New Jersey | 07094 | United States |
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Harlem Hospital Center | New York | New York | 10037 | United States |
| NYC Health + Hospitals/Lincoln | The Bronx | New York | 10451 | United States |
| Premier Family Physicians - Austin - Hunt - PPDS | Austin | Texas | 78735 | United States |
| Village Health Partners - Plano - Hunt - PPDS | Plano | Texas | 75024 | United States |
| South Texas Allergy and Asthma Medical Professionals | San Antonio | Texas | 78229 | United States |
| Boundary House Medical Centre | Sale | Cheshire | M33 2RH | United Kingdom |
| St Mary's Hospital - PPDS | London | City of London | W2 1NY | United Kingdom |
| Royal Free Hospital | London | NW3 2Q | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban | Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days. |
| BG001 | Placebo | Participants self-administered rivaroxaban matching placebo orally once daily for 21 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Up to Day 35 |
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| 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 35 |
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| 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 35 |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to Day 28 |
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| 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. | ITT Population. Only those participants with available data were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to Day 28 |
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| 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. | ITT Population. Only those participants with available data were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to Day 28 |
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| 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. | ITT Population | Posted | Count of Participants | Participants | Days 8, 14, and 21 |
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| 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. | ITT Population | Posted | Count of Participants | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population | Posted | Count of Participants | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population. Only those participants with available data were analyzed. | Posted | Count of Participants | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population. Only those participants with available data were analyzed. | Posted | Count of Participants | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population | Posted | Count of Participants | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population | Posted | Median | Full Range | Days | Up to Day 35 |
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| 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. | ITT Population | Posted | Number | Participants | Days 8, 14, 21, and 28 |
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| 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. | ITT Population | Posted | Number | Participants | Baseline; Days 8, 14, 21, and 28 |
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| 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. | Not Posted | Baseline; Days 8, 14, 21, and 28 | Participants | ||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Baseline; Days 8, 14, 21, and 28 | Participants |
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivaroxaban | Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days. | 0 | 219 | 2 | 219 | 12 | 219 |
| EG001 | Placebo | Participants self-administered rivaroxaban matching placebo orally once daily for 21 days. | 0 | 230 | 7 | 230 | 11 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDra 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| COVID -19/COVID-19 pneumonia/pneumonia | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
|
Based on Data Monitoring Committee's recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates MRI | +1 857 702 2108 | clinical.trials@gatesmri.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2021 | Sep 29, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Mixed race |
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| Other |
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| Unknown |
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| Participants |
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| Score 2 |
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| Score 7 |
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| Score 1 |
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