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

18. prosince 2021 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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].

Typ studie

Pozorovací

Zápis (Aktuální)

1309

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
asthma control
Časové okno: 3 month
study difference in asthma control between COVID and non COVID patients
3 month

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
difference between groups
Časové okno: 3 month
compare clinical and laboratory difference in parameters between the 3 groups
3 month

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. prosince 2020

Primární dokončení (Aktuální)

28. února 2021

Dokončení studie (Aktuální)

15. října 2021

Termíny zápisu do studia

První předloženo

11. prosince 2021

První předloženo, které splnilo kritéria kontroly kvality

18. prosince 2021

První zveřejněno (Aktuální)

21. prosince 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. prosince 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. prosince 2021

Naposledy ověřeno

1. prosince 2021

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

all collected data

Časový rámec sdílení IPD

after acceptance by journal, for 1 year

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na COVID-19

Klinické studie na no intervention

3
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