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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05054127
Other study ID # COVID-19 and CRD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2022
Est. completion date May 15, 2023

Study information

Verified date February 2022
Source Assiut University
Contact Reham El Morshedy, lecturer
Phone 01065060672
Email reham1715@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

1. To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases 2. To asses the severity of COVID-19 in patients with chronic respiratory diseases 3. To identify the outcome of COVID-19 in patients with chronic respiratory diseases


Description:

Genomes analysis reveal that SARS-CoV-2 presents unique features: optimal affinity for angiotensin converting enzyme 2 (ACE2) receptor and a polybasic cleavage site at the S1/S2 spike junction that determines infectivity and host range [3-4) Patients with SARS-CoV-2 infection may present symptoms ranging from mild to severe with a large portion of the population being asymptomatic carriers. The most common reported symptoms include fever (83%), cough (82%) and shortness of breath (31%) [5-6]. Patients suffering from chronic respiratory diseases (CRD) such as chronic respiratory failure, asthma, chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), pulmonary hypertension (PH), sarcoidosis or cystic fibrosis (CF), were immediately considered to be at risk of severe forms of COVID-19 [7]. Indeed, COVID-19 is responsible for various respiratory symptoms, from cough with dyspnea to acute respiratory distress syndrome (ARDS) in its most severe presentation [8-9]. In parallel, it has been shown that COVID-19 patients have an increased risk of venous thromboembolic disease [10]. There is concern that the respiratory complications of COVID-19 could be deleterious in patients with prior CRD. [11-12-13] During COVID-19 pandemic, studies mostly demonstrated that COPD was related with worse outcomes. There may be a few reasons why the course of COVID-19 in COPD patients has been worse. Firstly, COPD patients tend to be older and have more comorbidities which may increase COVID-19 severity [14]. Respiratory failure and hypoxemia, which are the most important causes of death in COVID-19 patients, are more common in COPD patients [15]. Although the exact mechanism of acute exacerbation of ILD is not fully understood, the current belief is that it can be caused by numerous triggers, including infection, or it can be idiopathic.(16) It is likely that respiratory infection with COVID-19 could trigger an exacerbation of underlying ILD and result in poor outcomes. There is similar concern regarding the possibility of exacerbation in patients with sarcoidosis, especially those with fibrotic manifestations.(17) 1. To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases 2. To asses the severity of COVID-19 in patients with chronic respiratory diseases 3. To identify the outcome of COVID-19 in patients with chronic respiratory diseases


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 15, 2023
Est. primary completion date April 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. patients with chronic respiratory diseases diagnosed with covid-19 infection by PCR 2. Patients aged 18 years and above Exclusion Criteria: 1. Patient aged below 18 years old. 2. Patients refuse to share in our study

Study Design


Intervention

Other:
foiiow up patients
observational study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Alqahtani JS, Oyelade T, Aldhahir AM, Alghamdi SM, Almehmadi M, Alqahtani AS, Quaderi S, Mandal S, Hurst JR. Prevalence, Severity and Mortality associated with COPD and Smoking in patients with COVID-19: A Rapid Systematic Review and Meta-Analysis. PLoS One. 2020 May 11;15(5):e0233147. doi: 10.1371/journal.pone.0233147. eCollection 2020. — View Citation

Çakir Edis E. Chronic Pulmonary Diseases and COVID-19. Turk Thorac J. 2020 Sep;21(5):345-349. doi: 10.5152/TurkThoracJ.2020.20091. Epub 2020 Sep 1. Review. — View Citation

Poissy J, Goutay J, Caplan M, Parmentier E, Duburcq T, Lassalle F, Jeanpierre E, Rauch A, Labreuche J, Susen S; Lille ICU Haemostasis COVID-19 Group. Pulmonary Embolism in Patients With COVID-19: Awareness of an Increased Prevalence. Circulation. 2020 Jul 14;142(2):184-186. doi: 10.1161/CIRCULATIONAHA.120.047430. Epub 2020 Apr 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary relation between covid 19 and patients with chronic respiratory diseases pattern of presentation of COVID-19 in patients with chronic respiratory diseases 2-To asses the severity of COVID-19 in patients with chronic respiratory diseases 3-To identify the outcome of COVID-19 in patients with chronic respiratory diseases The pattern of presentation of COVID-19 in patients with chronic respiratory diseases The severity of COVID-19 in patients with chronic respiratory diseases The outcome of COVID-19 in patients with chronic respiratory diseases Baseline
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