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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Bemiparin sodium
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Hospital Rey Juan Carlos
  • Clinica Universidad de NavarraRecruiting
  • Hospital Clinic
  • Hospital Sant Pau
  • Hospital Universitario Bellvitge
  • Fundación Jiménez Díaz
  • Hospital Clínico San carlos
  • Hospital Universitario La Paz
  • Complejo Hospitalario de Navarra
  • Hospital Universitario de Salamanca
  • Complejo Hospitalario de Toledo
  • Hospital Universitario Río Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prophylactic bemiparin (3,500 IU/day)

Full therapeutic bemiparin (weight adjusted)

Arm Description

Bemiparin 3,500 IU daily for 10 days

Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days

Outcomes

Primary Outcome Measures

Clinical deterioration
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2020
Last Updated
October 26, 2020
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT04604327
Brief Title
Comparison of Two Different Doses of Bemiparin in COVID-19
Acronym
BEMICOP
Official Title
Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2020 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic bemiparin (3,500 IU/day)
Arm Type
Active Comparator
Arm Description
Bemiparin 3,500 IU daily for 10 days
Arm Title
Full therapeutic bemiparin (weight adjusted)
Arm Type
Experimental
Arm Description
Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days
Intervention Type
Drug
Intervention Name(s)
Bemiparin sodium
Other Intervention Name(s)
Hibor
Intervention Description
Prophilactic vs full-dose for 10 days
Primary Outcome Measure Information:
Title
Clinical deterioration
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Lecumberri, MD, PhD
Phone
+34 948296397
Email
rlecumber@unav.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Lecumberri, Md, PhD
Organizational Affiliation
University of Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Rey Juan Carlos
City
Móstoles
State/Province
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanesa Sendín
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramón Lecumberri, MD, PhD
Phone
+34948255400
Email
rlecumber@unav.es
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Jiménez
Facility Name
Hospital Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Filella
Facility Name
Hospital Universitario Bellvitge
City
L'Hospitalet De Llobregat
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Pina
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Vidal
Facility Name
Hospital Clínico San carlos
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Botella
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Víctor Jiménez Yuste
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Galicia
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Marcos
Facility Name
Complejo Hospitalario de Toledo
City
Toledo
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cuesta
Facility Name
Hospital Universitario Río Hortega
City
Valladolid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Abadía

12. IPD Sharing Statement

Citations:
PubMed Identifier
35244208
Citation
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.
Results Reference
derived
PubMed Identifier
34638151
Citation
Marcos-Jubilar M, Carmona-Torre F, Vidal R, Ruiz-Artacho P, Filella D, Carbonell C, Jimenez-Yuste V, Schwartz J, Llamas P, Alegre F, Sadaba B, Nunez-Cordoba J, Yuste JR, Fernandez-Garcia J, Lecumberri R; BEMICOP Investigators. Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial. Thromb Haemost. 2022 Feb;122(2):295-299. doi: 10.1055/a-1667-7534. Epub 2021 Dec 29.
Results Reference
derived

Learn more about this trial

Comparison of Two Different Doses of Bemiparin in COVID-19

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