Covid19NCT05054127
Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases.
An observational study of Covid19 and Chronic Respiratory Disease, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Chronic Respiratory Disease
- What is being tested?
- foiiow up patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 15 May 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: patients with chronic respiratory diseases present with covid 19 infection
Who may be able to join
- patients with chronic respiratory diseases diagnosed with covid-19 infection by PCR
- Patients aged 18 years and above
Who cannot join
- Patient aged below 18 years old.
- Patients refuse to share in our study
Trial locations and contacts
No sites are listed yet.
About this study
- To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
- To asses the severity of COVID-19 in patients with chronic respiratory diseases
- To identify the outcome of COVID-19 in patients with chronic respiratory diseases
Read the 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)
- To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
- To asses the severity of COVID-19 in patients with chronic respiratory diseases
- To identify the outcome of COVID-19 in patients with chronic respiratory diseases
- Conditions
- Covid19, Chronic Respiratory Disease
- Being tested
- foiiow up patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foiiow up patientsOther
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start15 Apr 2022 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madonna Youssef Roshdy Kelada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054127
- Sponsor's protocol ID
- COVID-19 and CRD
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cakir 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.
PubMed 33031727Alqahtani 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.
PubMed 32392262Poissy 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. No abstract available.
PubMed 32330083
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases.
- ClinicalTrials.gov ID
- NCT05054127
- Acronym / sponsor ID
- COVID-19 and CRD
- Conditions
- Covid19, Chronic Respiratory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
- To asses the severity of COVID-19 in patients with chronic respiratory diseases
- To identify the outcome of COVID-19 in patients with chronic respiratory diseases
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)
- To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
- To asses the severity of COVID-19 in patients with chronic respiratory diseases
- To identify the outcome of COVID-19 in patients with chronic respiratory diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with chronic respiratory diseases present with covid 19 infection
Key inclusion criteria (2 listed)
- patients with chronic respiratory diseases diagnosed with covid-19 infection by PCR
- Patients aged 18 years and above
Key exclusion criteria (2 listed)
- Patient aged below 18 years old.
- Patients refuse to share in our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foiiow up patientsobservational study | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Background: PubMed 33031727Cakir 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.
- Background: PubMed 32392262Alqahtani 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.
- Background: PubMed 32330083Poissy 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. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Chronic Respiratory Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham El Morshedy, lecturer (01065060672, reham1715@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between covid 19 and patients with chronic respiratory diseases (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054127, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.