Comparison of Two Different Doses of Bemiparin in COVID-19

Phase 3

• Conditions: COVID-19
• Interventions: Drug: Bemiparin sodium

• Registration Number: NCT04604327
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-23
• Study Start: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-10-27
• Last Update Posted: 2020-10-27
• Primary Completion: 2021-05-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full therapeutic bemiparin (weight adjusted)	Bemiparin sodium	Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days
Prophylactic bemiparin (3,500 IU/day)	Bemiparin sodium	Bemiparin 3,500 IU daily for 10 days

Primary Outcome Measures

Name	Time	Method
Clinical deterioration	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.

Trial Locations

Locations (12)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital Clínico San carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Rey Juan Carlos; 🇪🇸 Móstoles, Madrid, Spain

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain