- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04789356
Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)
22 de julio de 2021 actualizado por: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)
This is a quasi-experimental study with risk-based allocation.
Public security and education professionals from the state government will be included.
In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19.
Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days).
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after).
All participants will be followed up for 12 months from inclusion in the study.
Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
6233
Fase
- Fase 4
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.
Ubicaciones de estudio
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Amazonas
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Manaus, Amazonas, Brasil, 69050-010
- Escola Normal Superior - Universidade do Estado do Amazonas
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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 a 49 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age between 18 and 49 years
- Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.
Exclusion Criteria:
- Prior vaccination for COVID-19;
- Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
- History of severe allergic reaction or anaphylaxis to study vaccine components;
- Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
- Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
- Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
- Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
- Pregnancy or breastfeeding.
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: High-risk individuals (with comorbidities)
Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine
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600 SU/dose; Two doses separated by 28 days (± 7 days).
Intramuscular (deltoid) administration.
Otros nombres:
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Sin intervención: Low-risk individuals (without comorbidities)
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19
Periodo de tiempo: 2 weeks after the second vaccine dose
|
Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.
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2 weeks after the second vaccine dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
Periodo de tiempo: After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose
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After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 after second dose
Periodo de tiempo: After second dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 after second dose
Periodo de tiempo: After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Median of clinical progression scores between moderate and severe cases
Periodo de tiempo: After first dose, up to 12 months.
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Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups
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After first dose, up to 12 months.
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Incidence density of clinical cases virologically confirmed as COVID-19
Periodo de tiempo: After first dose, up to 12 months.
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After first dose, up to 12 months.
|
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Mortality confirmed as COVID-19
Periodo de tiempo: After first dose, up to 12 months.
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Incidence density of deaths confirmed as COVID-19
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After first dose, up to 12 months.
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Incidence density of hospitalizations for any cause
Periodo de tiempo: After first dose, up to 12 months.
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After first dose, up to 12 months.
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Mortality from any cause
Periodo de tiempo: After first dose, up to 12 months.
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Density of mortality from any cause
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After first dose, up to 12 months.
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Adverse events
Periodo de tiempo: Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Frequency of adverse events associated with the need for medical care
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Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Humoral and cell-mediated immune response
Periodo de tiempo: Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants
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Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Detection of antibodies against SARS-CoV-2 in samples
Periodo de tiempo: Before each vaccine dose and every 3 months, up to 12 months of follow-up
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Before each vaccine dose and every 3 months, up to 12 months of follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Marcus Lacerda, MD, Fundação de Medicina Tropical Heitor Vieira Dourado
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 (Actual)
18 de marzo de 2021
Finalización primaria (Actual)
5 de julio de 2021
Finalización del estudio (Anticipado)
1 de marzo de 2022
Fechas de registro del estudio
Enviado por primera vez
5 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2021
Publicado por primera vez (Actual)
9 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAAE: 44076721.5.0000.0005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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
producto fabricado y exportado desde los 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. .
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