Oral blood thinners versus injectable blood thinners in preventing clotting disorders associated with COVID 19 infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033871
- Lead Sponsor
- Dhiraj Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
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.
2. Ages 25 to 75 years.
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 >=2 if female, >=1 if male; D-dimer levels >500 ng/mL or have previous history of malignancy, deep vein thrombosis (DVT), systemic embolism or ischaemic events.
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.
5. Documented informed consent
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.
Chronic liver disease ((e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN.
Chronic kidney disease (eGFR <30 mL/min/1.73m2).
History of intracranial bleeding in the last 3 months.
Bleeding diathesis, active peptic ulcer disease.
Pregnancy or first postpartum week.
Refractory hypertension (SBP >180 mmHg).
Any other contraindication listed in the local labelling of enoxaparin and rivaroxaban
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method