- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04913779
Safety and Effectiveness of an Immunobiological Drug in CoViD-19 (INPB001)
Study to Evaluate the Safety and Effectiveness of an Immunobiological Drug (Anti SARS-CoV-2) in the Treatment of Coronavirus Disease 2019 (CoViD-19)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is an adaptive phase II/III study that aims to analyze the efficacy and safety of a immunobiological drug (Anti SARS-CoV-2) in the treatment of CoViD-19. This treatment is a passive immunotherapy strategy developed as a purified F(ab')2 fraction of equine hyperimmune serum (Anti-SARS-CoV-2). The equine serum was generated from antigenic stimulation with the SARS-CoV-2 receptor binding domain (RBD) purified protein.
This type of product (equine hyperimmune serum F(ab')2) has been widely used in our country in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as anti-loxosceles, anti -latrodectus, anti-scorpionic, and anti-phoneutria, anti-bothropic, anti-micrurus, and anti-crotalic sera, all developed by the National Institute of Biological Production (ANLIS-Malbrán) and distributed free of charge in public hospitals in the country .
In the present study, evaluates the effect and safety of this immunobiological treatment in patients with COVID-19 that require hospitalization.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Guillermo A Keller, MD PhD
- Número de teléfono: 011-4961-0943
- Correo electrónico: gkeller@anlis.gob.ar
Copia de seguridad de contactos de estudio
- Nombre: Claudio Bonel, PhD
- Número de teléfono: 011-4303-1801
- Correo electrónico: cbonel@anlis.gob.ar
Ubicaciones de estudio
-
-
-
Ciudad Autónoma De Buenos Aires, Argentina, 1408
- Reclutamiento
- Hospital General de Agudos Donación Francisco J. Santojanni
-
Contacto:
- Guillermo A Keller, MD PhD
- Número de teléfono: 01149610943
- Correo electrónico: gkeller@anlis.gob.ar
-
Contacto:
- Claudio Bonel, PhD
- Número de teléfono: 011-4303-2492
- Correo electrónico: cbonel@anlis.gob.ar
-
Investigador principal:
- Guillermo A Keller, MD PhD
-
Sub-Investigador:
- Guillermo Di Girolamo, MD PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects over 18 years old and under 80 years old.
- Positive results by RT-PCR for SARS CoV-2
- Clinical picture compatible with respiratory compromise in the form of pneumonia attributed to COVID-19 (Stage 3, 4 or 5 according to the WHO scale), lasting up to 72 hours from the onset of symptoms to their evaluation to be incorporated into the study.
- Patient with good disposition towards the study and that signs the informed consent.
Exclusion Criteria:
- Patients with clinical disease corresponding to mild / asymptomatic forms (Absence of radiological infiltrate and risk factors, with normal auscultation and arterial saturation of oxygen (SatO2) greater than 95%)
- Patients with clinical disease corresponding to severe forms (Severe pneumonia: presence of severity criteria (ATS / IDSA), one of two major or three minor criteria.)
- Patients who have received other therapeutic strategies in the framework of an experimental study that make it difficult to evaluate the results obtained, including (but not limited to): convalescent plasma, lopinavir / ritonavir, hydroxychloroquine, and azithromycin.
- Pregnant or lactating women.
- Women of childbearing potential not using an effective contraceptive method (withdrawal, intrauterine device, or oral contraceptives).
- History of severe anaphylactic reaction with the administration of equine plasma.
- Patients with comorbidities that justify a risk of high mortality from causes independent of SARS-CoV-2 infection (eg, stage IV cancer)
- Patient who does not consent to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Anti-SARS-CoV-2
Administration of 10 ml of a concentrated equine hyperimmune serum solution with neutralizing activity of SARS-CoV-2 not less than1/5120, administered in slow intravenous infusion (10 ml diluted in100 ml of physiological solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
|
Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)
Otros nombres:
|
Comparador de placebos: Placebo
Administration of 10 ml of a control-solution with no-neutralizing activity of SARS-CoV-2, administered in slow intravenous infusion (10ml diluted in 100 ml of physiological solution, administered over 50 to60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0when incorporated into the study -initial dose- and at 48 hours -second dose-).
|
Administration of 10 ml of a control-solution without neutralizing activity against SARS-CoV-2, administered in slow intravenous infusion (10 ml diluted in 100 ml of saline solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in time needed to clinical improvement
Periodo de tiempo: Reached each day between day 1 and 28 post-inclusion in the study
|
In subjects admitted to the general ward for active infection by SARS-CoV-2 and a clinical picture of pneumonia who receive supportive treatment recommended by the guidelines of the Ministry of Health of the Argentine Nation (Population), if slow intravenous administration of Anti SARS-CoV-2 in two doses 48 hours apart (Intervention) added to supportive treatment, compared to supportive treatment alone (patients will receive slow intravenous administration of a placebo solution in two doses 48 hours apart to maintain the "blind" as Comparator), changes the time needed to clinical improvement (Outcome), during 28 days after the assignment (Time).
|
Reached each day between day 1 and 28 post-inclusion in the study
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in the number of patients in each World Health Organization (WHO) Ordinal Scale Category (0 to 8 being 0 better and 8 worse)
Periodo de tiempo: days 7, 14 and 21 post-inclusion
|
(a) Change in the number of patients in each World Health Organization Ordinal Scale Category (0 to 8 being 0 better and 8 worse), expecting a lower proportion of patients in categories 4, 5, 6, and 7 (OUTCOME - Efficacy);
|
days 7, 14 and 21 post-inclusion
|
Change in Mortality rate
Periodo de tiempo: 28 days post-inclusion
|
(b) Change of all-cause mortality at day 28 (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in Mechanical Ventilation Requirement rate
Periodo de tiempo: 28 days post-inclusion
|
(c) Determination of the frequency of invasive mechanical ventilation in the total analysis period (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in duration of oxygen treatment requirement
Periodo de tiempo: 28 days post-inclusion
|
(d) Change of the duration of oxygen therapy quantified in days of oxygen therapy (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in Length of Hospitalization
Periodo de tiempo: 28 days post-inclusion
|
(e) Change of hospital length of hospitalization, quantified in days from study inclusion until hospital discharge (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in frequency of nosocomial infection
Periodo de tiempo: 28 days post-inclusion
|
(F) Change in the frequency of patients with nosocomial infection (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in Lymphocyte cell count
Periodo de tiempo: 28 days post-inclusion
|
(g) Change of absolute lymphocyte count (OUTCOME - Efficacy);
|
28 days post-inclusion
|
Change in viral RNA Negativization rate on nasopharyngeal swab test
Periodo de tiempo: 7, 14, 21, and 28 days post-inclusion
|
(h) change in the proportion of patients with detected viral RNA and the viral RNA load, measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR), on day 7, 14, 21, and 28 (OUTCOME - Efficacy);
|
7, 14, 21, and 28 days post-inclusion
|
Description of adverse events type and frequency
Periodo de tiempo: 28 days post-inclusion
|
(i) description of reported adverse events, discriminated by their severity, and classified according to MedDRA (OUTCOME - Safety).
|
28 days post-inclusion
|
Requirement of additional treatments for Adverse Drug reactions
Periodo de tiempo: 28 days post-inclusion
|
(j) The number of subjects who required additional treatment as a consequence of reported adverse events in each therapeutic branch (OUTCOME - Safety)
|
28 days post-inclusion
|
Describe the AUC of purified F(ab')2 Anti-SARS-CoV-2
Periodo de tiempo: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
(k1) Describe area under the curve (AUC) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients
|
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
Describe the Cmax of purified F(ab')2 Anti-SARS-CoV-2
Periodo de tiempo: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
(k2) Describe maximum plasma concentration (Cmax) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
|
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
Describe the t1/2 of purified F(ab')2 Anti-SARS-CoV-2
Periodo de tiempo: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
(k3) Describe plasma half life (t1/2) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
|
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
Describe the Ke of purified F(ab')2 Anti-SARS-CoV-2
Periodo de tiempo: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
(k4) Describe elimination constant (Ke) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
|
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Guillermo A Keller, PhD, INPB - ANLIS Malbrán
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INPB001
- PRIISA.BA 2578 (Identificador de registro: PRIISA.BA)
- RENIS IS003268 (Identificador de registro: RENIS)
- DI-2021-2196-APN-ANMAT#MS (Otro identificador: Disposición ANMAT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
- Código analítico
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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 COVID-19
-
VA Office of Research and DevelopmentActivo, no reclutandoPacientes con EPOC y pacientes que se recuperan de COVID19Estados Unidos
-
HealthQuiltTerminadoFunción inmune | Paciente Positivo Covid19 | Covid19 contacto cercanoEstados Unidos
-
Bahçeşehir UniversityTerminadoLargo Covid19 | Disfunción autonómicaPavo
-
Ohio State UniversityReclutamientoSíndrome post-agudo de COVID19 | COVID largo | Condición posterior a COVID19Estados Unidos
-
Brugmann University HospitalReclutamiento
-
Assiut UniversityAún no reclutando
-
Istituti Clinici Scientifici Maugeri SpAIstituto Auxologico Italiano; Azienda Ospedaliera Bolognini di Seriate Bergamo; Azienda Socio Sanitaria Territoriale di Bergamo y otros colaboradoresTerminado
-
Bassett HealthcareBioreference, IncTerminadoInmunología Covid19Estados Unidos
-
Associazione Chirurghi Ospedalieri ItalianiTerminado
-
Gamaleya Research Institute of Epidemiology and...Government of the city of Moscow; CRO: Crocus Medical BVDesconocidoPrevención Covid19Federación Rusa
Ensayos clínicos sobre Anti-SARS-CoV-2
-
Orthosera Kft.University of Pecs; Semmelweis University; Hungarian National Blood Service; Humán...Reclutamiento
-
University of the PhilippinesTerminado
-
Medical College of WisconsinFroedtert HospitalTerminado
-
U.S. Army Medical Research and Development CommandYa no está disponibleSíndrome Respiratorio Agudo Severo Coronavirus 2Estados Unidos, Alemania, Afganistán, Yibuti, Guam, Irak, Japón, Kuwait
-
Institute for Transfusion Medicine of RNMUniversity Clinic for Infectious Diseases, North MacedoniaTerminadoCOVID-19 | SARS-CoV-2 | Plasma convalecienteMacedonia del norte
-
Johns Hopkins UniversityTerminadoCoronavirus | ConvalecenciaEstados Unidos
-
Noah MerinJohns Hopkins UniversityTerminadoCOVID-19 | SARS-CoV-2Estados Unidos
-
Johns Hopkins UniversityTerminadoInfección por SARS-CoV-2Estados Unidos
-
University of California, Los AngelesAún no reclutandoContagio de coronavirusEstados Unidos