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

NCT ID: NCT04420299

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2021-06-08

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.

Conditions

Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental - therapeutic bemiparin dose

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

Group Type: EXPERIMENTAL

Bemiparin

Intervention Type: DRUG

Bemiparin at therapeutic dose for 10 days

Control - prophylactic bemiparin dose

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

Group Type: EXPERIMENTAL

Bemiparin

Intervention Type: DRUG

Bemiparin at prophylactic dose for 10 days

Interventions

Bemiparin

Bemiparin at therapeutic dose for 10 days

Intervention Type: DRUG

Bemiparin

Bemiparin at prophylactic dose for 10 days

Intervention Type: DRUG

Other Intervention Names

Therapeutic dose; Prophylactic dose

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntax for Science, S.L

INDUSTRY

Sponsor Role: collaborator

Fundación de investigación HM

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Cubillo, MD

Role: STUDY_DIRECTOR

Director

Locations

Hospital Universitario HM Montepríncipe

Boadilla del Monte, Madrid, Spain

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35244208 (View on PubMed)

Other Identifiers

2020-001548-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BEMICOVID-19

Identifier Type: -

Identifier Source: org_study_id