Coronavirus Disease (COVID)19Phase 4NCT04584580
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
A Phase 4 study testing low-molecular-weight heparin in people with Coronavirus Disease (COVID)19, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease (COVID)19
- What is being tested?
- low-molecular-weight heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
Fatma Soliman E Ebeid, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
Read the 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
- Conditions
- Coronavirus Disease (COVID)19
- Being tested
- low-molecular-weight heparin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-molecular-weight heparinDrug
Also called Enoxaparin
low-molecular-weight heparin administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: low-molecular-weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
All cause mortality
Measured: 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)
Measured: Until patient is discharged or up to 4 weeks whichever comes first
Secondary outcomes (4)
occurrence of Sepsis-induced coagulopathy
calculation of sepsis induced coagulopathy (SIC) score
Measured: Until patient is discharged or up to 4 weeks whichever comes first
Occurrence of adult respiratory distress syndrome (ARDS)
Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio
Measured: Until patient is discharged or up to 4 weeks whichever comes first
Occurrence of sepsis
Calculation of sequential organ failure (SOFA) score
Measured: Until patient is discharged or up to 4 weeks whichever comes first
ICU admission and need for mechanical ventilation
occurrence of respiratory failure detected by arterial blood gases analysis
Measured: Until patient is discharged or up to 4 weeks whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Aug 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID)19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf M Madkour, Ain Shams University
- Investigators
- Ashraf Madkour, Principal investigator, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584580
- Sponsor's protocol ID
- FMASU P35/ 2020
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04584580
- Acronym / sponsor ID
- FMASU P35/ 2020
- Conditions
- Coronavirus Disease (COVID)19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic dose low-molecular-weight heparin (LMWH) | Active comparator | Drug: low-molecular-weight heparinTherapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours |
| D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy | Experimental | Drug: low-molecular-weight heparinfrom 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-molecular-weight heparinAlso: Enoxaparinlow-molecular-weight heparin administered via subcutaneous injection | Drug | D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy, Therapeutic dose low-molecular-weight heparin (LMWH) |
Primary outcome
mortality
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
All cause mortality
occurrence of venous and/or arterial thrombosis
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
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)
4 secondary outcomes
occurrence of Sepsis-induced coagulopathy
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
Occurrence of adult respiratory distress syndrome (ARDS)
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
Occurrence of sepsis
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
ICU admission and need for mechanical ventilation
Time frame: Until patient is discharged or up to 4 weeks whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 35244208Flumignan 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Related trials for Coronavirus Disease (COVID)19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Madkour principal investigator
Ain Shams University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-molecular-weight heparin in people with Coronavirus Disease (COVID)19, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Madkour (+20 100 177 0703, asfrah_madkour@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Until patient is discharged or up to 4 weeks whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.