RBR‐7nzwkpg.

Study name	Effects of treatment with oral anticoagulant associated with antibiotic therapy in COVID‐19
Methods	Prospective, double‐blind RCT
Participants	Number of participants: 160 Age: ≥ 18 years Gender: male and female Inclusion criteria Clinical suspicion of COVID‐19 Oxygen saturation between 93% and 97% At least 1 more symptom according to the Ministry of Health criteria including tiredness or shortness of breath, fever and chills, cough, and loss of smell or taste Positive result for the D‐dimer test Exclusion criteria Patients with active infectious diseases, immunosuppressive diseases, or active cancer Pregnant or lactating women Known renal failure Current use of anticoagulants Contraindication to the use of edoxaban or moxifloxacin
Interventions	Intervention: 1 non‐transparent bottle containing 28 tablets of edoxaban 60 mg. The prescription will obey the following dosage: 1 tablet, once daily, for 28 days. Control: 1 non‐transparent bottle containing 28 non‐transparent capsules. The capsules will contain standard placebo formulation, consisting of 0.5% magnesium stearate, 1.0% Aerosil, 30% pharmaceutical talc + starch q.s.p. The prescription will obey the following dosage: 1 capsule, once daily, for 28 days.
Outcomes	Primary outcome Frequency of individuals who required hospitalisation after starting treatment Secondary outcomes Secondary outcomes are not expected
Starting date	24 January 2021
Contact information	anna.piovezan@unisul.br
Notes

ALT: alanine transaminase
aPTT: activated partial thromboplastin clotting time
BMI: body mass index 
CAD: coronary artery disease
CNS: central nervous system
COPD: chronic obstructive pulmonary disease
CYP3A4: cytochrome P450 3A4 
DVT: deep vein thrombosis
ECG: electrocardiogram
ECMO: extracorporeal membrane oxygenation
EMR: electronic medical record
ER: emergency room
eGFR: estimated glomerular filtration rate
FIO₂: fraction of inspired oxygen
G6PD: glucose‐6‐phosphate dehydrogenase
GFR: glomerular filtration rate
HFOV: high‐frequency oscillatory ventilation
ICU: intensive care unit
IgM: immunoglobulin M
IMP: investigational medicinal product
INR: international normalised ratio
ISTH: International Society of Thrombosis and Haemostasis
LMWH: low‐molecular‐weight heparin
MACE: major cardiovascular events
MI: myocardial infarction
MVP: mechanical valve prosthesis
N: normal
NYHA: New York Heart Association
PAD: peripheral artery disease
PaO₂: partial pressure of arterial oxygen
PE: pulmonary embolism
P‐gp: P‐glycoprotein
PCR: polymerase chain reaction
QTc: corrected QT interval
RCT: randomised controlled trial
RT‐PCR: reverse transcription polymerase chain reaction
ULN: upper limit of normal
VTE: venous thromboembolism
WHO: World Health Organization