Comparison of Two Different Doses of Bemiparin in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-26

Study Completion Date

2021-07-31

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic bemiparin (3,500 IU/day)

Bemiparin 3,500 IU daily for 10 days

Group Type ACTIVE_COMPARATOR

Bemiparin sodium

Intervention Type DRUG

Prophilactic vs full-dose for 10 days

Full therapeutic bemiparin (weight adjusted)

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

Group Type EXPERIMENTAL

Bemiparin sodium

Intervention Type DRUG

Prophilactic vs full-dose for 10 days

Interventions

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Bemiparin sodium

Prophilactic vs full-dose for 10 days

Intervention Type DRUG

Other Intervention Names

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Hibor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramon Lecumberri, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Locations

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