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

NCT04584580 | Unknown Phase 4

• 1 other identifier: FMASU P35/ 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronavirus Disease (COVID)19

Outcome Measures

Primary Outcomes (2)

• mortality

  All cause mortality

  Until patient is discharged or up to 4 weeks whichever comes first

• occurrence of venous and/or arterial thrombosis

  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)

  Until patient is discharged or up to 4 weeks whichever comes first

Secondary Outcomes (4)

• occurrence of Sepsis-induced coagulopathy

  Until patient is discharged or up to 4 weeks whichever comes first

• Occurrence of adult respiratory distress syndrome (ARDS)

  Until patient is discharged or up to 4 weeks whichever comes first

• Occurrence of sepsis

  Until patient is discharged or up to 4 weeks whichever comes first

• ICU admission and need for mechanical ventilation

  Until patient is discharged or up to 4 weeks whichever comes first

Study Arms (2)

Therapeutic dose low-molecular-weight heparin (LMWH)

ACTIVE COMPARATOR

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

D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy

EXPERIMENTAL

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

Interventions

low-molecular-weight heparin DRUG

low-molecular-weight heparin administered via subcutaneous injection

Also known as: Enoxaparin

D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy; Therapeutic dose low-molecular-weight heparin (LMWH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Non-US, 11566, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 35244208 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Heparin, Low-Molecular-Weight; Enoxaparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Ashraf Madkour

  Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Madkour

CONTACT

+20 100 177 0703; asfrah_madkour@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: August 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

EG (1)