A Study of Rivaroxaban to Reduce the Risk of Major Venous... | NCT04508023

NCT04508023

ID	Type	Description	Link
39039039DVT3004	Other Identifier	Janssen Research & Development, LLC

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban	Experimental	Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).	Drug: Rivaroxaban Other: Standard of Care (SOC)
Placebo	Placebo Comparator	Participants will receive matching placebo tablet orally once daily for 35 Days along with SOC.	Other: Placebo Other: Standard of Care (SOC)

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	Participants will receive rivaroxaban 10 mg tablet orally once daily.	Rivaroxaban

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint	Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality.	Up to Day 35
Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria	Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal.	Up to Day 35

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes	Number of participants with time to the first occurrence of secondary efficacy outcomes which included thrombotic events (symptomatic VTE, myocardial infarction, ischemic stroke, acute limb ischemia, non-CNS systemic embolization), emergency room (ER) visit, all-cause mortality, all-cause hospitalization, any thrombotic outcome and all-cause mortality, and any thrombotic outcome and all-cause hospitalization, were reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral diagnostic test (example, polymerase chain reaction [PCR]). This may be nasal swab or saliva test or other available technology to demonstrate current infection
Confirm that participant is known to health system, with at least 1 contact in electronic medical records (EMR) prior to screening
Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell, muscle aches, shortness of breath, fatigue)
Initial treatment plan does not include hospitalization
Presence of at least 1 additional risk factor: a) age more than or equal to (>=) 60 years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal cell carcinoma) h) history of diabetes requiring medication; i) history of heart failure; j) body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2); k) D-dimer greater than (>) upper limit of normal for local laboratory (within 2 weeks of the date of the COVID-19 test and prior to randomization)

Exclusion Criteria:

Increased risk of bleeding such as a) significant bleeding in the last 3 months; b) active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e) prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and undergoing treatment
Any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (example recent trauma, recent surgery, severe uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis, severe liver disease, known bleeding diathesis)
Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic COVID-19 infection
Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85721	United States
Southern California Permanente Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37154020	Result	Piazza G, Spyropoulos AC, Hsia J, Goldin M, Towner WJ, Go AS, Bull TM, Weng S, Lipardi C, Barnathan ES, Bonaca MP; PREVENT-HD Investigators. Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial. Circulation. 2023 Jun 20;147(25):1891-1901. doi: 10.1161/CIRCULATIONAHA.123.063901. Epub 2023 May 8.
37591523

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 4, 2020	Jul 17, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
BG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000641 BG001643 BG0021284

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.3± 13.07 BG00155.7± 13.3 BG00256± 13.18

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000399 BG001384 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00095 BG00197 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0015 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000641 BG001643 BG002

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 Time to First Occurrence of Primary Efficacy Composite Endpoint

Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality.

Intent-To-Treat (ITT) analysis set included all randomized participants who provided informed consent.

Posted

Count of Participants

Participants

Up to Day 35

ID	Title	Description
OG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
OG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Units	Counts
Participants	OG000641 OG001643

Title

Denominators

Categories

Title	Measurements
	OG00022 OG00119

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Log rank test stratified by the time from COVID-19 positive test to randomization.	0.626		Cox Proportional Hazard	1.16			2-Sided	95	0.63	2.15					Superiority

Primary

Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal.

The safety analysis set included participants in ITT who received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Up to Day 35

ID	Title	Description
OG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
OG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Secondary

Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes

Number of participants with time to the first occurrence of secondary efficacy outcomes which included thrombotic events (symptomatic VTE, myocardial infarction, ischemic stroke, acute limb ischemia, non-CNS systemic embolization), emergency room (ER) visit, all-cause mortality, all-cause hospitalization, any thrombotic outcome and all-cause mortality, and any thrombotic outcome and all-cause hospitalization, were reported.

ITT analysis set included all randomized participants who provided informed consent.

Posted

Count of Participants

Participants

From Day 1 up to Day 35

ID	Title	Description
OG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
OG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Secondary

Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria

Number of participants with time to first occurrence of the major bleeding based on a modification of the ISTH criteria were reported. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 grams per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.

The safety analysis set included participants in ITT who received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Up to Day 35

ID	Title	Description
OG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
OG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Secondary

Number of Participants Who Were Hospitalized or Dead on Day 35

Number of participants who were hospitalized or dead on Day 35 were reported.

ITT analysis set included all randomized participants who provided informed consent.

Posted

Count of Participants

Participants

At Day 35 (+/- 6 days)

ID	Title	Description
OG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
OG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban 10 Milligrams (mg)	Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	2	641	1	599	57	599
EG001	Placebo	Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	2	643	0	598	50	598

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Drug Hypersensitivity	Immune system disorders	MedDRA Version 24.1	Non-systematic Assessment		EG0001 affected599 at risk EG0010 affected598 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Palpitations	Cardiac disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0012 affected598 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Eye Pruritus	Eye disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Vision Blurred	Eye disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0011 affected598 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0005 affected599 at risk EG0011 affected598 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected599 at risk EG0011 affected598 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected599 at risk EG0010 affected598 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0010 affected598 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Eructation	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0012 affected598 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0015 affected598 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Fatigue	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0010 affected598 at risk
Feeling Hot	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Injection Site Bruising	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Peripheral Swelling	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Vaccination Site Bruising	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Allergy to Animal	Immune system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Bacterial Infection	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Covid-19	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0003 affected599 at risk EG0012 affected598 at risk
Ear Infection	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Hordeolum	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Sinusitis	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0003 affected599 at risk EG0016 affected598 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Wound	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Liver Function Test Increased	Investigations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Oxygen Saturation Decreased	Investigations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Weight Increased	Investigations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Hyperphagia	Metabolism and nutrition disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0010 affected598 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected599 at risk EG0013 affected598 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0011 affected598 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Dizziness	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected599 at risk EG0012 affected598 at risk
Dizziness Exertional	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Dizziness Postural	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Dysarthria	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Headache	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0005 affected599 at risk EG0017 affected598 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Migraine	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0012 affected598 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Somnolence	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Syncope	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Anxiety	Psychiatric disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Insomnia	Psychiatric disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0011 affected598 at risk
Irritability	Psychiatric disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Nervousness	Psychiatric disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Polycystic Ovaries	Reproductive system and breast disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Pulmonary Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Throat Tightness	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0012 affected598 at risk
Blood Blister	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Pain of Skin	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected599 at risk EG0011 affected598 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0003 affected599 at risk EG0012 affected598 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected599 at risk EG0011 affected598 at risk
Peripheral Coldness	Vascular disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected599 at risk EG0010 affected598 at risk

The study was terminated prematurely due to enrollment challenges.

Certain Agreements

First MCP Posted Date

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000069552	Rivaroxaban
D059039	Standard of Care

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation