Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

CompletadoFase 3ClinicalTrials.gov

ID: NCT04535063Tipo: INTERVENTIONALInicio: 18 de abr de 2020Fin estimado: 25 de feb de 2021

Neumología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

Descripción detallada

COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult patients ≥18, and non-pregnant women
Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with \>50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.
days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -

Criterios de exclusión

More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
Pregnancy
Contraindication for plasma infusion because anaphylaxis history
Patients with high risk of circulatory overload
Limitation of therapeutic efforts
Refractory shock define by norepinephrine dose more than 1 ug/k/min
SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion

Intervenciones

biological

COVID19 convalescent plasma infusion

intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)

Ubicaciones

Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, Argentina

Patrocinadores

PrincipalCentro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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