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

NCT04420299 | Terminated Phase 2

• 2 other identifiers: BEMICOVID-192020-001548-24
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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

Keywords

covid-19; immunothrombosis; d-dimer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that worsen

  Combined worsening variable. Presence of any of the following will be considered worseing: 1. Death. 2. ICU admission. 3. Need for either non-invasive or invasive mechanical ventilation. 4. Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition). 5. Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).

  Day 10 +/- 1

Secondary Outcomes (15)

• Mortality from any cause at day 28

  Day 28

• Proportion of subjects that requires admission to the ICU

  From study start to day 28

• Proportion of subjects requiring non-invasive mechanical ventilation

  From study start to day 28

• Proportion of subjects requiring invasive mechanical ventilation.

  From study start to day 28

• Proportion of subjects with some organ failure

  From study start to day 28

Study Arms (2)

Experimental - therapeutic bemiparin dose

EXPERIMENTAL

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

Drug: Bemiparin

Control - prophylactic bemiparin dose

EXPERIMENTAL

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

Drug: Bemiparin

Interventions

Bemiparin DRUG

Bemiparin at therapeutic dose for 10 days

Also known as: Therapeutic dose

Experimental - therapeutic bemiparin dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación de investigación HM: lead
• Syntax for Science, S.L: collaborator

Study Sites (2)

Hospital Universitario HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Related Publications (1)

• 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.

  PMID: 35244208 DERIVED

MeSH Terms

Conditions

COVID-19; Thromboinflammation

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Cubillo, MD

  Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, single-blind, parallel control group

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 4, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)