Back to resultsClinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19
Primary Purpose
Covid-19
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Bemiparin
Bemiparin
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring covid-19, immunothrombosis, d-dimer
Eligibility Criteria
Inclusion Criteria:
- Informed consent.
- Age of 18 years or more.
- Patient with suspected COVID-19 and who meets hospitalization criteria.
- D-dimer> 500 ng / ml.
- Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains.
- Patient admitted to hospital
Exclusion Criteria:
- ICU admission criteria.
- Need for invasive or not invasive mechanical ventilation
- Pregnancy.
- Creatine clearance <30 ml / min (Cockroft-Gault).
- Severe liver or pancreatic function disorder.
- Acute bacterial endocarditis and slow endocarditis.
- Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
- Patient with high hemorrhagic risk due to previous medical-surgical history.
- Severe thrombocytopenia (<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
- Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies).
- Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
- Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
- Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.
Sites / Locations
- Hospital Universitario HM Montepríncipe
- Hospital Universitario HM Puerta del Sur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental - therapeutic bemiparin dose
Control - prophylactic bemiparin dose
Arm Description
Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days
Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days
Outcomes
Primary Outcome Measures
Proportion of patients that worsen
Combined worsening variable. Presence of any of the following will be considered worseing:
Death.
ICU admission.
Need for either non-invasive or invasive mechanical ventilation.
Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition).
Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).
Secondary Outcome Measures
Mortality from any cause at day 28
Mortality from any cause
Proportion of subjects that requires admission to the ICU
Proportion of subjects that requires admission to the ICU
Proportion of subjects requiring non-invasive mechanical ventilation
Proportion of subjects requiring non-invasive mechanical ventilation
Proportion of subjects requiring invasive mechanical ventilation.
Proportion of subjects requiring invasive mechanical ventilation.
Proportion of subjects with some organ failure
Proportion of subjects with some organ failure
Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
Proportion of subjects with pathological angioTAC
Proportion of subjects with pathological angioTAC at day 10 +/-1
Proportion of subjects with improvement in chest radiography
Proportion of subjects with improvement in chest radiography
Proportion and median hospital discharge between patients in both groups.
Proportion and median hospital discharge between patients in both groups.
Titration score
Titration score
Ferritin score
Ferritin score
D-dimer modification score
D-dimer modification score
Adverse events (total and serious).
Adverse events (total and serious)
Related adverse events (total and serious).
Related adverse events (total and serious).
Clinically relevant major and non major hemorrhages.
Clinically relevant major and non major hemorrhages.
Full Information
NCT ID
NCT04420299
First Posted
June 5, 2020
Last Updated
June 3, 2022
Sponsor
Fundación de investigación HM
Collaborators
Syntax for Science, S.L
1. Study Identification
Unique Protocol Identification Number
NCT04420299
Brief Title
Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19
Official Title
A Randomized, Single-blind Study With a Parallel Control Group on the Efficacy and Safety of Bemiparin at Therapeutic Dose vs. Prophylactic Dose in Patients Hospitalized for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number of patients specified in the protocol.
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
June 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de investigación HM
Collaborators
Syntax for Science, S.L
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of which many things are not yet known. Among others, there is a need to define the best therapeutic strategy to treat Covid-19, improving patients survival and reducing complications in its management, for which many different types of treatments are being tested.
The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or more veins, generally in the legs) and venous thromboembolism (when the clot can detach and lodge in other organs such as the lungs). Covid-19 patients have been shown to be at increased risk of developing clotting problems such as those described above.
In this context, this clinical trial is being carried out to find out if certain doses of bemiparin can contribute to better management of the disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
covid-19, immunothrombosis, d-dimer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, single-blind, parallel control group
Masking
Participant
Masking Description
Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental - therapeutic bemiparin dose
Arm Type
Experimental
Arm Description
Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days
Arm Title
Control - prophylactic bemiparin dose
Arm Type
Experimental
Arm Description
Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Other Intervention Name(s)
Therapeutic dose
Intervention Description
Bemiparin at therapeutic dose for 10 days
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Other Intervention Name(s)
Prophylactic dose
Intervention Description
Bemiparin at prophylactic dose for 10 days
Primary Outcome Measure Information:
Title
Proportion of patients that worsen
Description
Combined worsening variable. Presence of any of the following will be considered worseing:
Death.
ICU admission.
Need for either non-invasive or invasive mechanical ventilation.
Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition).
Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).
Time Frame
Day 10 +/- 1
Secondary Outcome Measure Information:
Title
Mortality from any cause at day 28
Description
Mortality from any cause
Time Frame
Day 28
Title
Proportion of subjects that requires admission to the ICU
Description
Proportion of subjects that requires admission to the ICU
Time Frame
From study start to day 28
Title
Proportion of subjects requiring non-invasive mechanical ventilation
Description
Proportion of subjects requiring non-invasive mechanical ventilation
Time Frame
From study start to day 28
Title
Proportion of subjects requiring invasive mechanical ventilation.
Description
Proportion of subjects requiring invasive mechanical ventilation.
Time Frame
From study start to day 28
Title
Proportion of subjects with some organ failure
Description
Proportion of subjects with some organ failure
Time Frame
From study start to day 28
Title
Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
Description
Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
Time Frame
From study start to day 28
Title
Proportion of subjects with pathological angioTAC
Description
Proportion of subjects with pathological angioTAC at day 10 +/-1
Time Frame
At day 10 +/-1
Title
Proportion of subjects with improvement in chest radiography
Description
Proportion of subjects with improvement in chest radiography
Time Frame
At day 10 +/-1
Title
Proportion and median hospital discharge between patients in both groups.
Description
Proportion and median hospital discharge between patients in both groups.
Time Frame
From study start to day 28
Title
Titration score
Description
Titration score
Time Frame
From study start to day 28
Title
Ferritin score
Description
Ferritin score
Time Frame
From study start to day 28
Title
D-dimer modification score
Description
D-dimer modification score
Time Frame
From study start to day 28
Title
Adverse events (total and serious).
Description
Adverse events (total and serious)
Time Frame
From study start to day 28
Title
Related adverse events (total and serious).
Description
Related adverse events (total and serious).
Time Frame
From study start to day 28
Title
Clinically relevant major and non major hemorrhages.
Description
Clinically relevant major and non major hemorrhages.
Time Frame
From study start to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent.
Age of 18 years or more.
Patient with suspected COVID-19 and who meets hospitalization criteria.
D-dimer> 500 ng / ml.
Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains.
Patient admitted to hospital
Exclusion Criteria:
ICU admission criteria.
Need for invasive or not invasive mechanical ventilation
Pregnancy.
Creatine clearance <30 ml / min (Cockroft-Gault).
Severe liver or pancreatic function disorder.
Acute bacterial endocarditis and slow endocarditis.
Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
Patient with high hemorrhagic risk due to previous medical-surgical history.
Severe thrombocytopenia (<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies).
Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cubillo, MD
Organizational Affiliation
Director
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario HM Montepríncipe
City
Boadilla Del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital Universitario HM Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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
Learn more about this trial
Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19
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