Status:
TERMINATED
Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19
Lead Sponsor:
Fundación de investigación HM
Collaborating Sponsors:
Syntax for Science, S.L
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04420299
Start Date
June 4 2020
End Date
June 8 2021
Last Update
June 7 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario HM Montepríncipe
Boadilla del Monte, Madrid, Spain, 28660
2
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain, 28938