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Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

8 de julio de 2020 actualizado por: Lifefactors Zona Franca, SAS

A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

Descripción general del estudio

Descripción detallada

The study population will be patients (≥18 years) hospitalized by COVID-19 but still with an early form of the disease (in states 1-3 of the ordinal scale) who do not require mechanical ventilation (invasive or non-invasive) and who can give their consent informed.

All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:

Experimental arm 1: Plasma with inactivation/reduction of pathogens from convalescent patients with COVID-19 and who at the same time receive support therapy, in the 200 - 250 mL scheme, on days 1 and 3 of the intervention.

Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.

Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.

This arm will be included once available. The supply of anti-COVID-19 human immunoglobulin produced by LifeFactors will be carried out once the national regulatory agency (Invima) grants authorization and/or the regulatory requirements for the production of medications are met.

Control arm: Standard (specific) therapy for COVID-19 according to the suggested pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are determined by the Colombian Health Regulatory Authorities.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

75

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Antioquia
      • Medellín, Antioquia, Colombia
        • LifeFactors Zona Franca SAS
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Obtaining the informed written consent before carrying out the study procedures, by the patients.
  2. Adult patients ≥18 years at the time of recruitment for the study.
  3. Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen <72 hours before randomization.
  4. Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:

    1. Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.),
    2. Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen.
  5. Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).
  6. Patients who do not have more than 10 days between the onset of symptoms (fever or cough) and the day of administration of treatment or the demonstration of the absence of anti-SARS-CoV-2 antibodies (patients with more than 10 days of symptoms they can only be included if a negative antibody result has been confirmed).

Exclusion Criteria:

  1. Patient in a state of pregnancy.
  2. Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
  3. Participation in any other clinical trial of an experimental treatment for COVID-19.
  4. At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
  5. Any incompatibility or allergy to the administration of plasma of human origin.
  6. Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate <30).
  7. Any condition that in the investigator's opinion limits participation in the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Convalescent plasma
Plasma from patients recovering from COVID-19.
Plasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.
Experimental: Anti-COVID-19 human immunoglobulin
Anti-COVID-19 human immunoglobulin to be administered intravenously.

Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment.

Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment.

The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met.

Comparador activo: Standard (specific) therapy

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.

To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.

To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Admission to ICU and/or mechanical ventilation
Periodo de tiempo: One year
Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.
One year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Length of hospital stay
Periodo de tiempo: One year
Time in the hospital from admission to discharge or death.
One year
Neutralizing antibody (IgG) titers against COVID-19
Periodo de tiempo: One year
Neutralizing antibody (IgG) titers against COVID-19
One year
Safety - Adverse events
Periodo de tiempo: One year
Non-serious adverse events (NSAEs) and serious adverse events (SAEs)
One year
Death
Periodo de tiempo: One year
Overall mortality
One year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de septiembre de 2020

Finalización primaria (Anticipado)

1 de diciembre de 2020

Finalización del estudio (Anticipado)

1 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2020

Publicado por primera vez (Actual)

20 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Enfermedad por coronavirus 2019 (COVID-19)

Ensayos clínicos sobre COVID-19 convalescent plasma

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