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

NCT05165953 | Completed

• 1 other identifier: TEJB-D-21-00113
• Study Type: observational
• Target: 1,309
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Asthma; COVID-19

Outcome Measures

Primary Outcomes (1)

• asthma control

  study difference in asthma control between COVID and non COVID patients

  3 month

Secondary Outcomes (1)

• difference between groups

  3 month

Study Arms (3)

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).

Other: no intervention

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).

Other: no intervention

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).

Other: no intervention

Interventions

no intervention OTHER

there was no intervention in the study

Group 1: COVID-19 positive with asthma; Group 2: COVID-19 positive with no asthma; Group 3: COVID-19 negative with asthma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

RAFA medical centre

Riyāḑ, Saudi Arabia

Location

MeSH Terms

Conditions

Asthma; COVID-19

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of chest diseases and tuberculosis

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: October 15, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after acceptance by journal, for 1 year

Locations

SA (1)