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Relationship Between Bronchial Asthma and COVID-19 Infection in Adults: Clinical and Laboratory Assessment

18 de diciembre de 2021 actualizado por: AMIRA HUSSEIN ALLAM, Benha University
Background: Asthma is still considered a major chronic respiratory disease that affects a large number in the world. The association between COVID-19 infection and asthma was studied in different ways focusing on hospital admitted patients. This study aimed to evaluate the relation between asthma and COVID-19 infection in adults attending outpatient pulmonary clinic over three successive months from clinical and laboratory point of view. Patients and methods: The current study collected 1309 patients attending the outpatient pulmonary clinic of a Saudi Arabian private Hospital over three successive months from 1st of December 2020 to the end of February 2021. Patients were divided into three groups; Group 1: COVID-19 infected with asthma (312), Group 2: COVID-19 infected with no asthma (286) and Group 3: COVID-19 non-infected with asthma (300).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The current study aimed to evaluate the relation between asthma and COVID-19 infection in adults attending outpatient pulmonary clinic over three successive months from clinical and laboratory point of view.

Patients and methods:

The current study is a retrospective analytical study on 1309 patients attending pulmonary clinic in a Saudi Arabian private hospital over three successive month's starting from the 1st of December 2020 to the end of February 2021. Patients were classified according to previous history of asthma and /or infection with covid -19 in the previous 6 months. Patients were divided into two main groups according to history of COVID-19 infection; history of COVID-19 infection , no history of COVID-19 infection. Each group was divided into asthma and non-asthma groups. Patients who had no history of asthma and had no history of previous infection with COVID-19 were excluded from the study. So, the investigators get three groups: Group 1: COVID-19 positive with asthma, Group 2: COVID-19 positive with no asthma and Group 3: COVID-19 negative with asthma. The study was approved by local internal ethics committee and patient's acceptance to reveal their data was received prior to the study.

Methods: data were collected from medical records including: history of COVID -19 infection, presenting symptoms and clinical examination, hospitalization either ICU or ward. For asthma patients, their full data were collected regarding asthma control in last 3 months following GINA criteria for asthma control [8], Investigations included; CBC with differential count, WBC, lymphocytes, eosinophils, HGB and platelets, Inflammatory markers as d-dimer, LDH and ferritin level, electrolytes, BUN, serum creatinine, CXR, and old spirometry reports.

Diagnosis of COVID 19 infection was made by a positive nasopharyngeal and throat swabs COVID 19 polymerase chain reaction (PCR). The data were collected from patients' medical records including medical history, demographic information such as age, gender, symptoms of COVID-19, time of onset of symptoms, the physical examination at admission, during hospitalization, medications prescribed for COIVID-19 treatment, laboratory examinations, and imaging tests which were performed for all groups.

The data were analyzed using SPSS 22 (SPSS Inc., Chicago, IL, USA). The results were presented as percentile (absolute numbers); mean and standard deviation. Quantitative data were presented as median (interquartile range) (IQR, presented as first quartile - third quartile). Qualitative data were expressed as percentage (%) [9].

Tipo de estudio

De observación

Inscripción (Actual)

1309

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

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients were classified according to previous history of asthma and /or infection with covid -19 in the previous 6 months. Patients were divided into two main groups according to history of COVID-19 infection; history of COVID-19 infection , no history of COVID-19 infection. Each group was divided into asthma and non-asthma groups. Patients who had no history of asthma and had no history of previous infection with COVID-19 were excluded from the study. So, we get three groups: Group 1: COVID-19 positive with asthma, Group 2: COVID-19 positive with no asthma and Group 3: COVID-19 negative with asthma.

Descripción

Inclusion Criteria: patients with diagnosis of COVID19 infection in the past 6month and/or patient with diagnosis of asthma

Exclusion Criteria:

  • patients with no history of COVID or asthma
  • other diagnoses as cardiac or COPD or bronchiectasis, tuberculosis etc

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Group 1: COVID-19 positive with asthma

data were collected from medical records including: history of COVID -19 infection, presenting symptoms and clinical examination, hospitalization either ICU or ward. For asthma patients, their full data were collected regarding asthma control in last 3 months following GINA criteria for asthma control [8], Investigations included; CBC with differential count, WBC, lymphocytes, eosinophils, HGB and platelets, Inflammatory markers as d-dimer, LDH and ferritin level, electrolytes, BUN, serum creatinine, CXR, and old spirometry reports.

Diagnosis of COVID 19 infection was made by a positive nasopharyngeal and throat swabs COVID 19 polymerase chain reaction (PCR).

there was no intervention in the study
Group 2: COVID-19 positive with no asthma

data were collected from medical records including: history of COVID -19 infection, presenting symptoms and clinical examination, hospitalization either ICU or ward. Investigations included; CBC with differential count, WBC, lymphocytes, eosinophils, HGB and platelets, Inflammatory markers as d-dimer, LDH and ferritin level, electrolytes, BUN, serum creatinine, CXR, and old spirometry reports.

Diagnosis of COVID 19 infection was made by a positive nasopharyngeal and throat swabs COVID 19 polymerase chain reaction (PCR).

there was no intervention in the study
Group 3: COVID-19 negative with asthma

data were collected from medical records including: history of COVID -19 infection, presenting symptoms and clinical examination, hospitalization either ICU or ward. For asthma patients, their full data were collected regarding asthma control in last 3 months following GINA criteria for asthma control [8], Investigations included; CBC with differential count, WBC, lymphocytes, eosinophils, HGB and platelets, Inflammatory markers as d-dimer, LDH and ferritin level, electrolytes, BUN, serum creatinine, CXR, and old spirometry reports.

Diagnosis of COVID 19 infection was made by a positive nasopharyngeal and throat swabs COVID 19 polymerase chain reaction (PCR).

there was no intervention in the study

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
asthma control
Periodo de tiempo: 3 month
study difference in asthma control between COVID and non COVID patients
3 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
difference between groups
Periodo de tiempo: 3 month
compare clinical and laboratory difference in parameters between the 3 groups
3 month

Colaboradores e Investigadores

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

Patrocinador

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)

1 de diciembre de 2020

Finalización primaria (Actual)

28 de febrero de 2021

Finalización del estudio (Actual)

15 de octubre de 2021

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de diciembre de 2021

Publicado por primera vez (Actual)

21 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de diciembre de 2021

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

18 de diciembre de 2021

Última verificación

1 de diciembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

all collected data

Marco de tiempo para compartir IPD

after acceptance by journal, for 1 year

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

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 COVID-19

Ensayos clínicos sobre no intervention

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