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

NCT ID: NCT04584580

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-31

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

Conditions

Coronavirus Disease (COVID)19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

low-molecular-weight heparin

Intervention Type: DRUG

low-molecular-weight heparin administered via subcutaneous injection

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

Group Type: EXPERIMENTAL

low-molecular-weight heparin

Intervention Type: DRUG

low-molecular-weight heparin administered via subcutaneous injection

Interventions

low-molecular-weight heparin

low-molecular-weight heparin administered via subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ashraf M Madkour

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Madkour

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University, Faculty of Medicine

Locations

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ashraf Madkour

Role: CONTACT

asfrah_madkour@yahoo.com

+20 100 177 0703

Facility Contacts

Fatma Soliman E Ebeid

Role: primary

dr.fatma_ebeid@yahoo.com

01095569596

References

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.

Reference Type: DERIVED

PMID: 35244208 (View on PubMed)

Other Identifiers

FMASU P35/ 2020

Identifier Type: -

Identifier Source: org_study_id