Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05054127
Recruitment Status : Not yet recruiting
First Posted : September 23, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Madonna Youssef Roshdy Kelada, Assiut University

Brief 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

Condition or disease Intervention/treatment
Covid19 Chronic Respiratory Disease Other: foiiow up patients

Detailed 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases.
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: foiiow up patients
    observational study


Primary Outcome Measures :
  1. relation between covid 19 and patients with chronic respiratory diseases [ Time Frame: Baseline ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic respiratory diseases present with covid 19 infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054127


Contacts
Layout table for location contacts
Contact: Reham El Morshedy, lecturer 01065060672 reham1715@gmail.com
Contact: Marwan Mohammed, lecturer 01009364307 lilamarwan2016@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
Layout table for additonal information
Responsible Party: Madonna Youssef Roshdy Kelada, Madonna youssef roshdy kelada, Assiut University
ClinicalTrials.gov Identifier: NCT05054127    
Other Study ID Numbers: COVID-19 and CRD
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiration Disorders
Respiratory Tract Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases