Covid19 in BronchiactasisNCT04910113
Bronchiactasis as Atypical Presentation in COVID-19
An observational study of Covid19 in Bronchiactasis, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the prevelance and pattern of bronchiectasis as atypical COVID-19 presentation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19 in Bronchiactasis
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Includes all patients admitted to Assuit police hospital diagnosed as COVID-19 positive by PCR and meet the inclusion criteria
Who may be able to join
- Significant sputum production (≥ 10 ml per day)
- Adult patients aged 18 years or older of both sex and diagnosed as COVID-19 positive by PCR either during same visit or in previous visits during the 2020-2021 who have CT scan examination of the chest during acute diseases or at follow up
Who cannot join
- Children under 18 years old, patients with known chronic chest diseases, and patients who are not examined by CT scan of the chest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchiectasis as Atypical Presentation in COVID-19: A Single Center Study
To evaluate the prevelance and pattern of bronchiectasis as atypical COVID-19 presentation
Read the detailed description
bronchiectasis is achronic inflammatory lung disease. It is defined by the presence of permanent and abnormal dilatation of the bronchi. which leads to chronic sputum production and impaired bacterial clearance. The affected parts of the lungs develop a vicious cycle of failed pathogen clearance leading to frequent infections, chronic inflammation and ongoing structural damage. The main symptoms are daily cough, daily sputum production and frequent respiratory infections. There is low frequency of non cystic fibrosis bronchiectasis The prevalence rate of NCFB in the general population was calculated to be 39.9 cases per 100,000.
There is an increasing prevalence of bronchiectasis in the elderly, affecting approximately 10 patients per 1,000 population.
A retrospective cohort study of health claims between 1999-2001 in the US suggested the prevalence of bronchiectasis to be 4.2 per 100,000 population aged 1834 years and 271.8 per 100,000 population aged >75 years . This usually occurs in the context of chronic airway infection causing inflammation. The main clinical manifestation is a productive cough. Bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (HRCT) scanning. The main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 12 cm of the lung fields.
Coronaviruses (CoVs) are a group of highly diverse, enveloped, positive-sense, and single-stranded RNA viruses.
In late December 2019, an outbreak of an unknown disease called pneumonia of unknown cause occurred in Wuhan, Hubei province, China.1 The outbreak has spread substantial to infect 9720 people in China with 213 deaths and to infect 106 people in 19 other countries up to 31 January 2020 . A few days later, the causative agent of this mysterious pneumonia was identified as a novel coronavirus (nCoV) by several independent laboratories.2-4 The causative virus has been temporarily named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the relevant infected disease has been named as coronavirus disease 2019 (COVID-19) by the World Health Organization, respectively. According to the daily report of the World Health Organization, the epidemic of SARS-CoV-2 so far registered 78630 cases and 2747 deaths in China, spread to 46 other countries that reported a total of 3664 cases by 27 February 2020 . COVID-19 epidemic has become a global health threat. Coronaviruses (CoVs) are a group of highly diverse, enveloped, positive-sense, and single-stranded RNA viruses.5 They cause several diseases involving respiratory, enteric, hepatic, and neurological systems with vary severity among humans and animals.6,7 The envelope spike (S) protein is important for CoV.19 The S protein mediates receptor binding and membrane fusion and is crucial for determining host tropism and transmission capacity.8,9,10 The final etiologic diagnosis of COVID-19 is nessary can be farther further confirmed with a positive real-time RT-PCR assay for COVID-19 using respiratory or blood samples or by means of viral gene sequencing of respiratory or blood samples that are highly homologous with COVID-19.
The typical chest CT findings include multifocal bilateral ground-glass opacities (GGOs) with patchy consolidations, prominent peripherally subpleural distribution, and posterior part or lower lobe predilection.
The long-term sequelae of COVID-19 remain to be investigated, although several publications have reported a fibrotic phase with reticulation characteristics, interlobar septal thickening, and traction bronchiectasis.
The onset and development of bronchiectasis during the follow-up of COVID-19 patients with pneumonia are under-reported.
- Conditions
- Covid19 in Bronchiactasis
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of bronchiectasis among COVID-19 patients
To evaluate the prevelance and pattern of bronchiectasis as atypical COVID-19 presentation
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 in BronchiactasisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ahmed Abd El-Gawad Mohamed Okash, Assiut University
- Investigators
- Ahmed Shaddad, Lecture, Principal investigator, Assuit University - Assuit - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910113
- Sponsor's protocol ID
- COVID in Bronchiactasis
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiectasis as Atypical Presentation in COVID-19: A Single Center Study
- ClinicalTrials.gov ID
- NCT04910113
- Acronym / sponsor ID
- COVID in Bronchiactasis
- Conditions
- Covid19 in Bronchiactasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 2 Jun 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 evaluate the prevelance and pattern of bronchiectasis as atypical COVID-19 presentation
Detailed description
bronchiectasis is achronic inflammatory lung disease. It is defined by the presence of permanent and abnormal dilatation of the bronchi. which leads to chronic sputum production and impaired bacterial clearance. The affected parts of the lungs develop a vicious cycle of failed pathogen clearance leading to frequent infections, chronic inflammation and ongoing structural damage. The main symptoms are daily cough, daily sputum production and frequent respiratory infections. There is low frequency of non cystic fibrosis bronchiectasis The prevalence rate of NCFB in the general population was calculated to be 39.9 cases per 100,000.
There is an increasing prevalence of bronchiectasis in the elderly, affecting approximately 10 patients per 1,000 population.
A retrospective cohort study of health claims between 1999-2001 in the US suggested the prevalence of bronchiectasis to be 4.2 per 100,000 population aged 1834 years and 271.8 per 100,000 population aged >75 years . This usually occurs in the context of chronic airway infection causing inflammation. The main clinical manifestation is a productive cough. Bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (HRCT) scanning. The main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 12 cm of the lung fields.
Coronaviruses (CoVs) are a group of highly diverse, enveloped, positive-sense, and single-stranded RNA viruses.
In late December 2019, an outbreak of an unknown disease called pneumonia of unknown cause occurred in Wuhan, Hubei province, China.1 The outbreak has spread substantial to infect 9720 people in China with 213 deaths and to infect 106 people in 19 other countries up to 31 January 2020 . A few days later, the causative agent of this mysterious pneumonia was identified as a novel coronavirus (nCoV) by several independent laboratories.2-4 The causative virus has been temporarily named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the relevant infected disease has been named as coronavirus disease 2019 (COVID-19) by the World Health Organization, respectively. According to the daily report of the World Health Organization, the epidemic of SARS-CoV-2 so far registered 78630 cases and 2747 deaths in China, spread to 46 other countries that reported a total of 3664 cases by 27 February 2020 . COVID-19 epidemic has become a global health threat. Coronaviruses (CoVs) are a group of highly diverse, enveloped, positive-sense, and single-stranded RNA viruses.5 They cause several diseases involving respiratory, enteric, hepatic, and neurological systems with vary severity among humans and animals.6,7 The envelope spike (S) protein is important for CoV.19 The S protein mediates receptor binding and membrane fusion and is crucial for determining host tropism and transmission capacity.8,9,10 The final etiologic diagnosis of COVID-19 is nessary can be farther further confirmed with a positive real-time RT-PCR assay for COVID-19 using respiratory or blood samples or by means of viral gene sequencing of respiratory or blood samples that are highly homologous with COVID-19.
The typical chest CT findings include multifocal bilateral ground-glass opacities (GGOs) with patchy consolidations, prominent peripherally subpleural distribution, and posterior part or lower lobe predilection.
The long-term sequelae of COVID-19 remain to be investigated, although several publications have reported a fibrotic phase with reticulation characteristics, interlobar septal thickening, and traction bronchiectasis.
The onset and development of bronchiectasis during the follow-up of COVID-19 patients with pneumonia are under-reported.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Includes all patients admitted to Assuit police hospital diagnosed as COVID-19 positive by PCR and meet the inclusion criteria
Key inclusion criteria (2 listed)
- Significant sputum production (≥ 10 ml per day)
- Adult patients aged 18 years or older of both sex and diagnosed as COVID-19 positive by PCR either during same visit or in previous visits during the 2020-2021 who have CT scan examination of the chest during acute diseases or at follow up
Key exclusion criteria (1 listed)
- Children under 18 years old, patients with known chronic chest diseases, and patients who are not examined by CT scan of the chest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of bronchiectasis among COVID-19 patients
Time frame: 1year
To evaluate the prevelance and pattern of bronchiectasis as atypical COVID-19 presentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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.
Ahmed Shaddad, Lecture principal investigator
Assuit University - Assuit - Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 in Bronchiactasis, run by Assiut University at 1 site in Egypt.
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 1 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Maha Ahmed Okasha (01002660421, maha.ahmed201388@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of bronchiectasis among COVID-19 patients (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2021.