D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia

Phase 4

• Conditions: Coronavirus Disease (COVID)19
• Interventions: Drug: low-molecular-weight heparin

• Registration Number: NCT04584580
• Lead Sponsor: Ain Shams University

Brief Summary

evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.

Detailed Description

The following will be done for enrolled patients:

1. Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.

2. Clinical examination Vital data Local chest examination

3. Measurement of oxygen saturation using pulse oximeter

4. Laboratory investigations:

Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile

5. Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed)

6. Sepsis-induced coagulopathy score (SIC score)

7. Sequential organ failure score (SOFA score)

8. Patients will receive treatment according to the hospital guidelines for different disease stratification severity

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-10
• Last Update Submitted: 2020-10-10
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult (>18 years) patients from both sexes with COVID-19 pneumonia with positive nucleic acid test for severe acute respiratory syndrome Coronavirus (SARS-CoV-2) hospitalized either in the ward or intensive care unit

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Exclusion Criteria

• Patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation
• Congenital hemorrhagic disorders
• Hypersensitivity to heparin
• Personal history of heparin-induced thrombocytopenia
• Active major bleeding or conditions predisposing to major bleeding. Major bleeding is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g.intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level (Hb) of ≥2g/dL in a 24h period, or c) leads to transfusion of 2 or more units of whole blood or red blood cells (13).
• Suspected or confirmed bacterial endocarditis
• Ongoing or planned therapeutic anticoagulation for any other indication
• Platelet count <50,000/μL within the past 24 hours or Hb level <8g/dL
• Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
• Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
• Fibrinogen <2.0 g/L
• Severe renal impairment (CrCl<30 mL/min) or acute kidney injury
• Use of dual antiplatelet therapy
• Pregnancy
• Unwillingness to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy	low-molecular-weight heparin	from admission until the end of hospital stay. Patients will be stratified according to their body weight and D-dimer level and receive LMWH D-Dimer level Body Weight LMWH dose \<1 mg/dl \<100kg Enoxaparin 40mg OD 100-150kg Enoxaparin 40mg BD \>150kg Enoxaparin 60mg BD 1-3 mg/ dl \<100kg Enoxaparin 40mg BD 100-150kg Enoxaparin 80mg BD \>150kg Enoxaparin 120mg BD \>3 mg/ dl Enoxaparin 80mg BD
Therapeutic dose low-molecular-weight heparin (LMWH)	low-molecular-weight heparin	Therapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours

Primary Outcome Measures

Name	Time	Method
mortality	Until patient is discharged or up to 4 weeks whichever comes first	All cause mortality
occurrence of venous and/or arterial thrombosis	Until patient is discharged or up to 4 weeks whichever comes first	clinical signs supported by radiological evidence of arterial thrombosis or venous thromboembolism (e.g. venous or arterial duplex and CT scan of the chest with pulmonary angiography)

Secondary Outcome Measures

Name	Time	Method
occurrence of Sepsis-induced coagulopathy	Until patient is discharged or up to 4 weeks whichever comes first	calculation of sepsis induced coagulopathy (SIC) score
Occurrence of adult respiratory distress syndrome (ARDS)	Until patient is discharged or up to 4 weeks whichever comes first	Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio
Occurrence of sepsis	Until patient is discharged or up to 4 weeks whichever comes first	Calculation of sequential organ failure (SOFA) score
ICU admission and need for mechanical ventilation	Until patient is discharged or up to 4 weeks whichever comes first	occurrence of respiratory failure detected by arterial blood gases analysis

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt