COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55087

Kaimaparambil

vaishnavikm94@gmail.com

2021-05-31

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Participants were enrolled after RT PCR-evidence of COVID-19 infection or radiological evidence of COVID-19 associated mild or moderate infection requiring hospitalisation. <br/ >2. Ages 25 to 75 years. <br/ >3. If mild infection (uncomplicated URTI without evidence of breathlessness or hypoxia [SpO2 >94% as defined by local guidelines), to be included if CHADSVASc2 score is â?¥2 if female, â?¥1 if male, D-dimer levels >500 ng/mL or have previous history of malignancy, deep vein thrombosis (DVT), systemic embolism or ischaemic events. <br/ >4. All patients with moderate infection (features of pneumonia with dyspnoea, hypoxia [SpO2 90-94%], respiratory rate >23/minute as defined by local guidelines) to be included regardless of CHADSVASC score and D-D-dimer levels. <br/ >5. Documented informed consent

<br/ > Severe disease (pneumonia with SpO2 <90% or respiratory rate >30/minute or severe respiratory distress) or critical illness (signs of shock, sepsis, multi-organ failure. <br/ >Chronic liver disease ((e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN. <br/ >Chronic kidney disease (eGFR <30 mL/min/1.73m2). <br/ >History of intracranial bleeding in the last 3 months. <br/ >Bleeding diathesis, active peptic ulcer disease. <br/ >Pregnancy or first postpartum week. <br/ >Refractory hypertension (SBP >180 mmHg). <br/ >Any other contraindication listed in the local labelling of enoxaparin and rivaroxaban

2

Dhiraj Kumar

25

70

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

200

Composite of all major haemorrhagic and thrombotic eventsTimepoint: Duration of hospital stay; time to event

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1124, "treatment_name": "Rivaroxaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]