Covid-19
Conditions
Keywords
covid-19, immunothrombosis, d-dimer
Brief summary
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.
Interventions
DRUGBemiparin
Bemiparin at therapeutic dose for 10 days
Sponsors
Syntax for Science, S.L
Fundación de investigación HM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
Intervention model description
randomized, single-blind, parallel control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that worsen | Day 10 +/- 1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects that requires admission to the ICU | From study start to day 28 | Proportion of subjects that requires admission to the ICU |
| Proportion of subjects requiring non-invasive mechanical ventilation | From study start to day 28 | Proportion of subjects requiring non-invasive mechanical ventilation |
| Proportion of subjects requiring invasive mechanical ventilation. | From study start to day 28 | Proportion of subjects requiring invasive mechanical ventilation. |
| Proportion of subjects with some organ failure | From study start to day 28 | Proportion of subjects with some organ failure |
| Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline | From study start to day 28 | Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline |
| Proportion of subjects with pathological angioTAC | At day 10 +/-1 | Proportion of subjects with pathological angioTAC at day 10 +/-1 |
| Proportion of subjects with improvement in chest radiography | At day 10 +/-1 | Proportion of subjects with improvement in chest radiography |
| Mortality from any cause at day 28 | Day 28 | Mortality from any cause |
| Titration score | From study start to day 28 | Titration score |
| Ferritin score | From study start to day 28 | Ferritin score |
| D-dimer modification score | From study start to day 28 | D-dimer modification score |
| Adverse events (total and serious). | From study start to day 28 | Adverse events (total and serious) |
| Related adverse events (total and serious). | From study start to day 28 | Related adverse events (total and serious). |
| Clinically relevant major and non major hemorrhages. | From study start to day 28 | Clinically relevant major and non major hemorrhages. |
| Proportion and median hospital discharge between patients in both groups. | From study start to day 28 | Proportion and median hospital discharge between patients in both groups. |
Countries
Spain
Outcome results
None listed