跳至主要内容
临床试验/CTRI/2021/05/033871
CTRI/2021/05/033871已完成2 期

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

Dhiraj Kumar0 个研究点目标入组 230 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
230

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Dhiraj Kumar

相似试验