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

Unknown status
Coronavirus Disease (COVID)19

Drug: low-molecular-weight heparin

low-molecular-weight heparin administered via subcutaneous injection
Other Name: Enoxaparin

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Egypt
Locations

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

Investigator: Fatma Soliman E Ebeid
Contact: 01095569596
dr.fatma_ebeid@yahoo.com

Contacts

Ashraf Madkour
+20 100 177 0703
asfrah_madkour@yahoo.com

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

Ain Shams University
NCT Number
MeSH Terms
Pneumonia
Heparin
Enoxaparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin