El ensayo clínico está próximo a iniciar en España, con el fin de determinar si un medicamento desarrollado por la farmacéutica Grifols es eficaz para dar inmunidad al Covid-19. El fármaco tiene como base la inmunoglobulina Gamunex-C y también contiene anticuerpos policlonales que se obtienen a partir de donantes de plasma sanguíneo que han superado la enfermedad.
Se espera que el medicamento proporcione protección inmediata postexposición al coronavirus. Este podría usarse como un complemento a la vacuna en fase temprana, el inicio de la prueba empezará a inicios del mes de febrero y los resultados se sabrán hacia mediados de junio.
En el estudio participarán 800 voluntarios asintomáticos positivos para Covid-19 en test diagnóstico, a quienes se les administrará el medicamento por vía subcutánea, teniendo en cuenta que la inmunoglobulina de esta farmacéutica está aprobada desde hace más de 15 años y a mostrado ser efectiva y segura para prevenir diferentes enfermedades infecciosas.
El fármaco de prueba podría resultar más efectivo en personas mayores y pacientes con inmunosupresión cuya vacunación no es recomendada. Adicionalmente, podría mitigar los brotes en lugares donde no haya iniciado la vacunación o sean de difícil acceso.
Los investigadores de Grifols sostienen que el tratamiento “proporcionaría una combinación de anticuerpos policlonales que, frente a los monoclonales, presentan una mayor diversidad que podría mejorar la capacidad de protección frente al virus”
También puede leer: 34.673 profesionales de la salud contagiados y 185 fallecidos por Covid-19
medicamento de fácil conservación
De otro lado, el medicamento posee ventajas que las vacunas no, como su facilidad de conservación que ayudarían a que la distribución fuera más sencilla, además de poner suministrase en cualquier lugar evitando el desplazamiento a hospitales y centros de salud.
“Si se confirma su eficacia, la nueva terapia se podría administrar a personas que hubieran dado positivo en test de antígenos y PCR en redes sanitarias de atención primaria” explicó el director médico de Grifols, Antonio Páez.
Finalmente, hacia mediados de octubre de 2020 Grifols inició en articulación con otras compañías estadounidenses un ensayo clínico denominado ITAC, para mostrar la eficacia y seguridad de la inmunoglobulina hiperinmune anti-SARS-CoV-2 en pacientes internados graves. Se espera que los resultados del estudio se conozcan en la primera mitad del 2021.
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