COVID-19NCT06374420
Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome
An observational study of COVID-19, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Apr 2024
- How long will I take part?
- 6 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.
Who may be able to join
- Ambulatory adult patients confirmed diagnosis of covid -19 either on typical CT chest basis or PCR and passed period of acute illness (28 days from start of symptoms) but still with clinical symptoms.
Who cannot join
- Hospitalized or requiring intensive care unit. Known patients with chronic lung diseases Uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors.
Read the detailed description
This is a observational longitudinal study investigating pulmonary sequelae of covid-19.
Study site:
Mansoura university hospital, chest department and post covid outpatient clinic.
Elmahalla chest hospital and outpatients clinic.
Time of study :
Two years from September 2021 to September 2023
Target population:
Adults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.
Sample size The study will include 100 selected cases during period from 2021 to 2023
Patients :
The enrolled patients are adults who survived acute covid-19 and presented for clinical follow up.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
investigating pulmonary sequelae of covid-19.
The selected post covid patients on the day of their clinic visit (one to three months after being diagnosed covid 19
Measured: 3moth
investigating pulmonary sequelae of covid-19.
The selected post covid patients on the day of their clinic visit (6 months after being diagnosed covid 19
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Sep 2021
- Primary completion1 Sep 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Awad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374420
- Sponsor's protocol ID
- MD.21.11.564
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome
- ClinicalTrials.gov ID
- NCT06374420
- Acronym / sponsor ID
- MD.21.11.564
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 18 Apr 2024 (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.
The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors.
Detailed description
This is a observational longitudinal study investigating pulmonary sequelae of covid-19.
Study site:
Mansoura university hospital, chest department and post covid outpatient clinic.
Elmahalla chest hospital and outpatients clinic.
Time of study :
Two years from September 2021 to September 2023
Target population:
Adults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.
Sample size The study will include 100 selected cases during period from 2021 to 2023
Patients :
The enrolled patients are adults who survived acute covid-19 and presented for clinical follow up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.
Key inclusion criteria (1 listed)
- Ambulatory adult patients confirmed diagnosis of covid -19 either on typical CT chest basis or PCR and passed period of acute illness (28 days from start of symptoms) but still with clinical symptoms.
Key exclusion criteria (1 listed)
- Hospitalized or requiring intensive care unit. Known patients with chronic lung diseases Uncontrolled comorbidities
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
investigating pulmonary sequelae of covid-19.
Time frame: 3moth
The selected post covid patients on the day of their clinic visit (one to three months after being diagnosed covid 19
investigating pulmonary sequelae of covid-19.
Time frame: 6 month
The selected post covid patients on the day of their clinic visit (6 months after being diagnosed covid 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by Mansoura 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 1 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: finished, as of the sponsor's last update on 19 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigating pulmonary sequelae of covid-19. (time frame: 3moth). The study lists 2 primary outcomes in all. 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 19 Apr 2024.