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NCT04604327 Clinical Trial

Comparison of Two Different Doses of Bemiparin in COVID-19

COVID-19 Clinical Trial

— BEMICOP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04604327
Other study ID # BEMICOP
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 26, 2020
Est. completion date July 31, 2021

Study information
Verified date October 2020
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Ramon Lecumberri, MD, PhD
Phone +34 948296397
Email rlecumber@unav.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 164
Est. completion date July 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bemiparin sodium
Prophilactic vs full-dose for 10 days

Locations
Country Name City State
Spain Hospital Clinic Barcelona
Spain Hospital Sant Pau Barcelona
Spain Hospital Universitario Bellvitge L'Hospitalet De Llobregat
Spain Fundación Jiménez Díaz Madrid
Spain Hospital Clínico San carlos Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Rey Juan Carlos Móstoles Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital Universitario de Salamanca Salamanca
Spain Complejo Hospitalario de Toledo Toledo
Spain Hospital Universitario Río Hortega Valladolid

Sponsors (1)
Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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