Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19

Fundación de investigación HM

Status and phase: Terminated; Phase 2

Conditions: Covid-19

Treatments: Drug: Bemiparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04420299

2020-001548-24 (EudraCT Number)

BEMICOVID-19

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent.
2. Age of 18 years or more.
3. Patient with suspected COVID-19 and who meets hospitalization criteria.
4. D-dimer> 500 ng / ml.
5. 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.
6. Patient admitted to hospital

Exclusion criteria

1. ICU admission criteria.
2. Need for invasive or not invasive mechanical ventilation
3. Pregnancy.
4. Creatine clearance <30 ml / min (Cockroft-Gault).
5. Severe liver or pancreatic function disorder.
6. Acute bacterial endocarditis and slow endocarditis.
7. Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
8. Patient with high hemorrhagic risk due to previous medical-surgical history.
9. Severe thrombocytopenia (<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
10. 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).
11. Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
12. Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
13. Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

81 participants in 2 patient groups

Experimental - therapeutic bemiparin dose

Experimental group

Description:

Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days

Treatment:

Drug: Bemiparin

Drug: Bemiparin

Control - prophylactic bemiparin dose

Experimental group

Description:

Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days

Treatment:

Drug: Bemiparin

Drug: Bemiparin