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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420299
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Syntax for Science, S.L
Information provided by (Responsible Party):
Fundación de investigación HM

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.


Condition or disease Intervention/treatment Phase
Covid-19 Drug: Bemiparin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, single-blind, parallel control group
Masking: Single (Participant)
Masking Description: Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Experimental - therapeutic bemiparin dose
Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days
Drug: Bemiparin
Bemiparin at therapeutic dose for 10 days
Other Name: Therapeutic dose

Experimental: Control - prophylactic bemiparin dose
Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days
Drug: Bemiparin
Bemiparin at prophylactic dose for 10 days
Other Name: Prophylactic dose




Primary Outcome Measures :
  1. Proportion of patients that worsen [ Time Frame: Day 10 +/- 1 ]

    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).


Secondary Outcome Measures :
  1. Mortality from any cause at day 28 [ Time Frame: Day 28 ]
    Mortality from any cause

  2. Proportion of subjects that requires admission to the ICU [ Time Frame: From study start to day 28 ]
    Proportion of subjects that requires admission to the ICU

  3. Proportion of subjects requiring non-invasive mechanical ventilation [ Time Frame: From study start to day 28 ]
    Proportion of subjects requiring non-invasive mechanical ventilation

  4. Proportion of subjects requiring invasive mechanical ventilation. [ Time Frame: From study start to day 28 ]
    Proportion of subjects requiring invasive mechanical ventilation.

  5. Proportion of subjects with some organ failure [ Time Frame: From study start to day 28 ]
    Proportion of subjects with some organ failure

  6. Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline [ Time Frame: From study start to day 28 ]
    Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline

  7. Proportion of subjects with pathological angioTAC [ Time Frame: At day 10 +/-1 ]
    Proportion of subjects with pathological angioTAC at day 10 +/-1

  8. Proportion of subjects with improvement in chest radiography [ Time Frame: At day 10 +/-1 ]
    Proportion of subjects with improvement in chest radiography

  9. Proportion and median hospital discharge between patients in both groups. [ Time Frame: From study start to day 28 ]
    Proportion and median hospital discharge between patients in both groups.

  10. Titration score [ Time Frame: From study start to day 28 ]
    Titration score

  11. Ferritin score [ Time Frame: From study start to day 28 ]
    Ferritin score

  12. D-dimer modification score [ Time Frame: From study start to day 28 ]
    D-dimer modification score

  13. Adverse events (total and serious). [ Time Frame: From study start to day 28 ]
    Adverse events (total and serious)

  14. Related adverse events (total and serious). [ Time Frame: From study start to day 28 ]
    Related adverse events (total and serious).

  15. Clinically relevant major and non major hemorrhages. [ Time Frame: From study start to day 28 ]
    Clinically relevant major and non major hemorrhages.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420299


Contacts
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Contact: Antonio Cubillo, MD +34 917567800 secretaria@fundaciónhm.com

Locations
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Spain
Hospital Universitario HM Montepríncipe Recruiting
Boadilla Del Monte, Madrid, Spain, 28660
Contact: José Felipe Varona, MD         
Principal Investigator: José Felipe Varona, MD         
Hospital Universitario HM Puerta del Sur Recruiting
Móstoles, Madrid, Spain, 28938
Contact: Elena Nuñez Cuerda, MD         
Principal Investigator: Elena Nuñez Cuerda, MD         
Sponsors and Collaborators
Fundación de investigación HM
Syntax for Science, S.L
Investigators
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Study Director: Antonio Cubillo, MD Director
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Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT04420299    
Other Study ID Numbers: BEMICOVID-19
2020-001548-24 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de investigación HM:
covid-19
immunothrombosis
d-dimer
Additional relevant MeSH terms:
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Heparin, Low-Molecular-Weight
Bemiparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action