Clinical trial NCT04584580: D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
Official title: D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronavirus Disease (COVID)19
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: mortality
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
measure: occurrence of venous and/or arterial thrombosis
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
Secondary outcomes:
measure: occurrence of Sepsis-induced coagulopathy
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
measure: Occurrence of adult respiratory distress syndrome (ARDS)
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
measure: Occurrence of sepsis
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
measure: ICU admission and need for mechanical ventilation
timeFrame: Until patient is discharged or up to 4 weeks whichever comes first
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Ain Shams University, Faculty of Medicine
name: Ashraf Madkour
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.