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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04584580
Collaborator
(none)
50
1
2
5
10

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: low-molecular-weight heparin
Phase 4

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

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

  2. Sepsis-induced coagulopathy score (SIC score)

  3. Sequential organ failure score (SOFA score)

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Therapeutic dose low-molecular-weight heparin (LMWH)

Therapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours

Drug: low-molecular-weight heparin
low-molecular-weight heparin administered via subcutaneous injection
Other Names:
  • Enoxaparin
  • Experimental: D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy

    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

    Drug: low-molecular-weight heparin
    low-molecular-weight heparin administered via subcutaneous injection
    Other Names:
  • Enoxaparin
  • Outcome Measures

    Primary Outcome Measures

    1. mortality [Until patient is discharged or up to 4 weeks whichever comes first]

      All cause mortality

    2. 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

    1. occurrence of Sepsis-induced coagulopathy [Until patient is discharged or up to 4 weeks whichever comes first]

      calculation of sepsis induced coagulopathy (SIC) score

    2. 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

    3. Occurrence of sepsis [Until patient is discharged or up to 4 weeks whichever comes first]

      Calculation of sequential organ failure (SOFA) score

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center Cairo Non-US Egypt 11566

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ashraf Madkour, Ain Shams University, Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ashraf M Madkour, Professor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04584580
    Other Study ID Numbers:
    • FMASU P35/ 2020
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2020