Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19

Phase 2TerminatedNCT04420299

Fundación de investigación HM81 enrolled

Overview

The 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of which many things are not yet known. Among others, there is a need to define the best therapeutic strategy to treat Covid-19, improving patients survival and reducing complications in its management, for which many different types of treatments are being tested. The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or more veins, generally in the legs) and venous thromboembolism (when the clot can detach and lodge in other organs such as the lungs). Covid-19 patients have been shown to be at increased risk of developing clotting problems such as those described above. In this context, this clinical trial is being carried out to find out if certain doses of bemiparin can contribute to better management of the disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Covid-19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent. 2. Age of 18 years or more. 3. Patient with suspected COVID-19 and who meets hospitalization criteria. 4. D-dimer\> 500 ng / ml. 5. Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains. 6. Patient admitted to hospital Exclusion Criteria: 1. ICU admission criteria. 2. Need for invasive or not invasive mechanical ventilation 3. Pregnancy. 4. Creatine clearance \<30 ml / min (Cockroft-Gault). 5. Severe liver or pancreatic function disorder. 6. Acute bacterial endocarditis and slow endocarditis. 7. Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit). 8. Patient with high hemorrhagic risk due to previous medical-surgical history. 9. Severe thrombocytopenia (\<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia. 10. Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies). 11. Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months. 12. Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate. 13. Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

Outcomes

Primary Outcomes

Proportion of patients that worsen

Combined worsening variable. Presence of any of the following will be considered worseing: 1. Death. 2. ICU admission. 3. Need for either non-invasive or invasive mechanical ventilation. 4. Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition). 5. Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).

Time frame: Day 10 +/- 1

Secondary Outcomes

Mortality from any cause at day 28

Mortality from any cause

Time frame: Day 28

Proportion of subjects that requires admission to the ICU

Time frame: From study start to day 28

Proportion of subjects requiring non-invasive mechanical ventilation

Time frame: From study start to day 28

Proportion of subjects requiring invasive mechanical ventilation.

Time frame: From study start to day 28

Proportion of subjects with some organ failure

Time frame: From study start to day 28

Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline

Time frame: From study start to day 28

Proportion of subjects with pathological angioTAC

Proportion of subjects with pathological angioTAC at day 10 +/-1

Time frame: At day 10 +/-1

Proportion of subjects with improvement in chest radiography

Time frame: At day 10 +/-1

Proportion and median hospital discharge between patients in both groups.

Time frame: From study start to day 28

Titration score

Time frame: From study start to day 28

Ferritin score

Time frame: From study start to day 28

D-dimer modification score

Time frame: From study start to day 28

Adverse events (total and serious).

Adverse events (total and serious)

Time frame: From study start to day 28

Related adverse events (total and serious).

Time frame: From study start to day 28

Clinically relevant major and non major hemorrhages.

Time frame: From study start to day 28

Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes