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

Primary Purpose

Coronavirus Disease (COVID)19

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

low-molecular-weight heparin

About this trial

This is an interventional supportive care trial for Coronavirus Disease (COVID)19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Therapeutic dose low-molecular-weight heparin (LMWH)

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

mortality

All cause mortality

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)

Secondary Outcome Measures

occurrence of Sepsis-induced coagulopathy

calculation of sepsis induced coagulopathy (SIC) score

Occurrence of adult respiratory distress syndrome (ARDS)

Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio

Occurrence of sepsis

Calculation of sequential organ failure (SOFA) score

ICU admission and need for mechanical ventilation

occurrence of respiratory failure detected by arterial blood gases analysis

Full Information

NCT ID

NCT04584580

First Posted

October 6, 2020

Last Updated

October 10, 2020

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04584580

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

October 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

Detailed Description

The following will be done for enrolled patients: Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions. Clinical examination Vital data Local chest examination Measurement of oxygen saturation using pulse oximeter Laboratory investigations: Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed) Sepsis-induced coagulopathy score (SIC score) Sequential organ failure score (SOFA score) Patients will receive treatment according to the hospital guidelines for different disease stratification severity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease (COVID)19

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic dose low-molecular-weight heparin (LMWH)

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

low-molecular-weight heparin

Other Intervention Name(s)

Enoxaparin

Intervention Description

low-molecular-weight heparin administered via subcutaneous injection

Primary Outcome Measure Information:

Title

mortality

Description

All cause mortality

Time Frame

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

Title

occurrence of venous and/or arterial thrombosis

Description

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)

Time Frame

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

Secondary Outcome Measure Information:

Title

occurrence of Sepsis-induced coagulopathy

Description

calculation of sepsis induced coagulopathy (SIC) score

Time Frame

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

Title

Occurrence of adult respiratory distress syndrome (ARDS)

Description

Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio

Time Frame

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

Title

Occurrence of sepsis

Description

Calculation of sequential organ failure (SOFA) score

Time Frame

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

Title

ICU admission and need for mechanical ventilation

Description

occurrence of respiratory failure detected by arterial blood gases analysis

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashraf Madkour

Phone

+20 100 177 0703

asfrah_madkour@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashraf Madkour

Organizational Affiliation

Ain Shams University, Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cairo

State/Province

Non-US

ZIP/Postal Code

11566

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatma Soliman E Ebeid

Phone

01095569596

dr.fatma_ebeid@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

35244208

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.

Results Reference

derived

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

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