COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004279-42/ES

Not reported

Not reported

2022-10-14

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients admitted to hospital with COVID-19, PCR + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC) 2. Patients with, at least, one of the following evolution disease risk criteria: -Sat 02<94% -Need for oxygen therapy or pAO2/FiO2<300mmHg -DD>1000µg/L -PCR >150mg/L -IL6 >40pg/ml 3. Age > 18 years 4. Weight 50-100 Kg 5. After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study. 1. Pacientes ingresados por neumonía COVID-19, PCR + infección SARS-CoV-2 o (presencia de infiltrado compatible en Rx tórax o TC). 2. Pacientes con al menos uno de los siguientes criterios de riesgo de evolución de la enfermedad: -Sat 02<94% --DD>1000µg/L -PCR >150mg/L -IL6 >40pg/ml 3. Edad > 18 años 4. Peso entre 50 y 100 kg 5. Después de haber recibido la información verbal y escrita acerca del estudio, el paciente debe entregar el Consentimiento Informado firmado y fechado antes de realizar ninguna actividad relacionada con el estudio.

1. Patients who need mechanical ventilation or admission to ICU at the moment of randomization. 2. Current diagnosis of acute bronchial asthma attack. 3. History or clinical suspicion of pulmonary fibrosis. 4. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis. 5. Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation. 6. Patients with pneumonectomy or lobectomy. 7. Renal failure with MDRD<30 ml/min 8. Patients with contraindication for anticoagulant treatment. 9. Congenital bleeding disorders. 10. Hypersensitivity to tinzaparin or UFH or some of its excipients. 11. History of heparin-induced thrombocytopenia. 12. Active bleeding or situation that predispose to bleeding. 13. Moderate or severe anaemia (Hb<10 g/dl) 14. Low platelet count < 80000/µl 15. Patients with life expectancy less than 3 months due to primary disease evaluated by the physician. 16. Patients currently intubated or intubated between the screening and the randomization. 17. Pregnancy. 1. Pacientes que requieran ventilación mecánica o ingreso en UCI en el momento de la aleatorización. 2. Diagnóstico actual de ataque de asma bronquial agudo 3. Historia o sospecha clínica de fibrosis pulmonar 4. Diagnóstico actual de sospecha de tromboembolismo pulmonar o trombosis venosa profunda. 5. Pacientes que requieran tratamiento anticoagulante por una enfermedad trombótica venosa o arterial previa, o por fibrilación auricular. 6. Pacientes con neumonectomía o lobectomía 7. Insuficiencia renal con MDRD<30 ml/min 8. Pacientes con contraindicación a la anticoagulación 9. Trastornos hemorrágicos congénitos 10. Hipersensibilidad a la tinzaparina o HNF o a alguno de sus excipientes 11. Antecedentes de trombocitopenia inducida por heparina 12. Hemorragia activa o situaciones que predispongan a una hemorragia. 13. Anemia moderada o grave (Hb<10 g/dl) 14. Plaquetopenia < 80000/µl 15. Pacientes con una esperanza de vida inferior a 3 meses debido a la enfermedad primaria evaluada por el médico. 16. Actualmente intubado o intubado entre cribado y aleatorización. 17. Embarazo

7

Fundación para la Investigación e Innovación Biomédica (FIIB) del HU Infanta Leonor y HU Sureste

18

100

Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

600

Efficacy: Combined variable that includes reduction of suspicion of systemic thrombotic symptomatic events and/or need for mechanical ventilation and/or death at day 30 after randomization. Eficacia: Variable combinada que incluye reducción de los eventos sistémicos trombóticos sintomáticos y/o necesidad de ventilación mecánica y/o muerte en los 30 días desde la aleatorización.

Declared number of arm (3.0) differs from found arms (7.0)

Phase 3

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