COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001722-66/ES

Clinical Trial Unit - CTU

acruceta@clinic.cat

2020-04-27

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1-Age 18-79 years, 2-Diagnosis of COVID-19 by PCR in nasopharyngeal, sputum or bronchial aspirate smears : 3-Admission to ICU with invasive mechanical ventilation, 4-Telephone informed consent granted by family members or legal representative. 1-Edad 18-79 años, 2-Diagnóstico de enfermedad COVID-19 por PCR en frotis nasofaringeo, esputo o broncoaspirado 3, 3-Ingreso en UCI con ventilación mecánica invasiva, 4-Consentimiento informado telefónico otorgado por familiares o representante legal.

1-> 7 days of invasive mechanical ventilation, 2- Refractory shock (norepinephrine> 0.5 microg / Kg / min), 3- Decompensated liver cirrhosis 4- Chronic hemodialysis 5- Active neoplastic disease 6- Moderate or severe heart failure (NYHA III- IV), 7- Moderate-severe lung disease (GOLD III-IV), 8- HIV with AIDS criteria. 1- > 7 días de ventilación mecánica invasiva, 2- Shock refractario (noradrenalina > 0.5 microg/Kg/min), 3- Cirrosis hepática descompensada 4- Hemodiálisis crónica 5- Enfermedad neoplásica activa 6- Insuficiencia cardiaca moderada o grave (NYHA III-IV), 7- Enfermedad pulmonar moderada-grave (GOLD III-IV), 8- VIH con criterios SIDA.

2

Fundació Clínic per a la recerca Biomèdica

18

79

Spain

Critical disease at enrollment

8: Critical disease at enrollment

116

Impact of plasma exchange on the rate and probability of survival 28 days after inclusion. Impacto del recambio plasmático sobre la tasa y probabilidad de supervivencia a los 28 días de la inclusión

nan

Phase 2

[{"arm_notes": "", "treatment_id": 588, "treatment_name": "Human albumin serum", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 600, "treatment_name": "Human normal albumin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]