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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001548-24 | EudraCT Number |
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Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number of patients specified in the protocol.
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| Name | Class |
|---|---|
| Syntax for Science, S.L | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - therapeutic bemiparin dose | Experimental | Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days |
|
| Control - prophylactic bemiparin dose | Experimental | Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemiparin | Drug | Bemiparin at therapeutic dose for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that worsen | Combined worsening variable. Presence of any of the following will be considered worseing:
| Day 10 +/- 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality from any cause at day 28 | Mortality from any cause | Day 28 |
| Proportion of subjects that requires admission to the ICU | Proportion of subjects that requires admission to the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Cubillo, MD | Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario HM MonteprÃncipe | Boadilla del Monte | Madrid | 28660 | Spain | ||
| Hospital Universitario HM Puerta del Sur |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000090882 | Thromboinflammation |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C411345 | bemiparin |
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randomized, single-blind, parallel control group
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Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
| Bemiparin | Drug | Bemiparin at prophylactic dose for 10 days |
|
|
| From study start to day 28 |
| Proportion of subjects requiring non-invasive mechanical ventilation | Proportion of subjects requiring non-invasive mechanical ventilation | From study start to day 28 |
| Proportion of subjects requiring invasive mechanical ventilation. | Proportion of subjects requiring invasive mechanical ventilation. | From study start to day 28 |
| Proportion of subjects with some organ failure | Proportion of subjects with some organ failure | From study start to day 28 |
| Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline | Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline | From study start to day 28 |
| Proportion of subjects with pathological angioTAC | Proportion of subjects with pathological angioTAC at day 10 +/-1 | At day 10 +/-1 |
| Proportion of subjects with improvement in chest radiography | Proportion of subjects with improvement in chest radiography | At day 10 +/-1 |
| Proportion and median hospital discharge between patients in both groups. | Proportion and median hospital discharge between patients in both groups. | From study start to day 28 |
| Titration score | Titration score | From study start to day 28 |
| Ferritin score | Ferritin score | From study start to day 28 |
| D-dimer modification score | D-dimer modification score | From study start to day 28 |
| Adverse events (total and serious). | Adverse events (total and serious) | From study start to day 28 |
| Related adverse events (total and serious). | Related adverse events (total and serious). | From study start to day 28 |
| Clinically relevant major and non major hemorrhages. | Clinically relevant major and non major hemorrhages. | From study start to day 28 |
| Móstoles |
| Madrid |
| 28938 |
| Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |