Skip to content

Oral blood thinners versus injectable blood thinners in preventing clotting disorders associated with COVID 19 infection

Oral versus Parenteral anticoagulation in the prophylaxis and therapeutic management of thromboembolic disease in hospitalised patients with confirmed COVID-19 disease

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033871
Enrollment
200
Registered
2021-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Rivaroxaban: 10mg or 15mg per oral, once daily
duration of hospital stay or 15days, whichever is longer Control Intervention1: Enoxaparin: 40mg or 60mg subcutaneous, once daily
duration of hospital stay or 15days, whichever is longer

Sponsors

Dhiraj Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Exclusion criteria: Severe disease (pneumonia with SpO2 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 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactKaimaparambil

SevenHills Dedicated COVID Hospital

vaishnavikm94@gmail.com09892075408

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026