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

University of Navarra

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Drug: Bemiparin sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04604327

BEMICOP

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Prophylactic bemiparin (3,500 IU/day)

Active Comparator group

Description:

Bemiparin 3,500 IU daily for 10 days

Treatment:

Drug: Bemiparin sodium

Full therapeutic bemiparin (weight adjusted)

Experimental group

Description:

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

Treatment:

Drug: Bemiparin sodium