NCT04604327

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

October 23, 2020

Last Update Submit

October 26, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Study Arms (2)

Prophylactic bemiparin (3,500 IU/day)

ACTIVE COMPARATOR

Bemiparin 3,500 IU daily for 10 days

Drug: Bemiparin sodium

Full therapeutic bemiparin (weight adjusted)

EXPERIMENTAL

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

Drug: Bemiparin sodium

Interventions

Bemiparin sodiumDRUG

Prophilactic vs full-dose for 10 days

Also known as: Hibor
Full therapeutic bemiparin (weight adjusted)Prophylactic bemiparin (3,500 IU/day)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Rey Juan Carlos

Móstoles, Madrid, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Spain

NOT YET RECRUITING

Fundación Jiménez Díaz

Madrid, Spain

NOT YET RECRUITING

Hospital Clínico San carlos

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Spain

NOT YET RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Spain

NOT YET RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

NOT YET RECRUITING

Complejo Hospitalario de Toledo

Toledo, Spain

NOT YET RECRUITING

Hospital Universitario Río Hortega

Valladolid, Spain

NOT YET RECRUITING

Related Publications (2)

  • 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: 35244208DERIVED

  • 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.

    PMID: 34638151DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ramon Lecumberri, Md, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramon Lecumberri, MD, PhD

CONTACT

+34 948296397rlecumber@unav.es

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 27, 2020

Study Start

October 26, 2020

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

ES(12)