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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05165953
Other study ID # TEJB-D-21-00113
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date October 15, 2021

Study information

Verified date December 2021
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

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].


Recruitment information / eligibility

Status Completed
Enrollment 1309
Est. completion date October 15, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
there was no intervention in the study

Locations

Country Name City State
Saudi Arabia RAFA medical centre Riyad

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary asthma control study difference in asthma control between COVID and non COVID patients 3 month
Secondary difference between groups compare clinical and laboratory difference in parameters between the 3 groups 3 month
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