Comparison of Two Different Doses of Bemiparin in COVID-19 (BEMICOP)

October 26, 2020 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19

Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic
        • Contact:
          • Sonia Jiménez
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Sant Pau
        • Contact:
          • David Filella
      • L'Hospitalet De Llobregat, Spain
        • Not yet recruiting
        • Hospital Universitario Bellvitge
        • Contact:
          • Elena Pina
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Victor Jimenez Yuste
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Ernesto Botella
      • Madrid, Spain
        • Not yet recruiting
        • Fundación Jiménez Díaz
        • Contact:
          • Rosa Vidal
      • Pamplona, Spain
        • Not yet recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Tania Galicia
      • Salamanca, Spain
        • Not yet recruiting
        • Hospital Universitario de Salamanca
        • Contact:
          • Miguel Marcos
      • Toledo, Spain
        • Not yet recruiting
        • Complejo Hospitalario de Toledo
        • Contact:
          • Jorge Cuesta
      • Valladolid, Spain
        • Not yet recruiting
        • Hospital Universitario Rio Hortega
        • Contact:
          • Jessica Abadía
    • Madrid
      • Móstoles, Madrid, Spain
        • Not yet recruiting
        • Hospital Rey Juan Carlos
        • Contact:
          • Vanesa Sendín
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age (equal or more than 18 yo)
  • Hospitalization at conventional wards due to COVID-19 related mild or moderate pneumonia (CURB65<3 points; Sat. O2>90%)
  • 3-4 points according to the WHO ordinal scale.
  • Confirmed COVID-19 (PCR or other validated test)
  • D-dimer >500 ng/mL
  • Sign of informed consent
  • The patient is able, according to investigator's opinion, to deal with all the requirements of the clinical trial.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic bemiparin (3,500 IU/day)
Bemiparin 3,500 IU daily for 10 days
Drug: Bemiparin sodium
Prophilactic vs full-dose for 10 days
Other Names:
  • Hibor
Experimental: Full therapeutic bemiparin (weight adjusted)
Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days
Drug: Bemiparin sodium
Prophilactic vs full-dose for 10 days
Other Names:
  • Hibor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical deterioration
Time Frame: 10 days
Combined outcome that includes number of patients who suffer any of the following: Death, ICU admission, mechanical ventilatory support, progression to moderate or severe ARDS (according to Berlin criteria) or arterial or venous thrombosis.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Ramon Lecumberri, Md, PhD, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 26, 2020

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEMICOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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