Covid19NCT04554251
Global Impact of COVID-19 on Pulmonology Special Units
An observational study of Covid19 and Global Impact, run by Assiut University at 1 site in Egypt.
Trial summary
The COVID-19 pandemic is having a profound impact on the world. As of May 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. The healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Global Impact, Pulmonology
- What is being tested?
- Survey
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: invited pulmonology units; bronchoscopy, thoracoscopy, chest ultrasonography and sleep lab
Who may be able to join
- Working registered invited pulmonology units; governmental, university, private
Who cannot join
- non pulmonary medicine registered units
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Impact of COVID-19 on Pulmonology Special Units (Bronchoscopy, Thoracoscopy, Ultrasonography and Sleep Lab)
The COVID-19 pandemic is having a profound impact on the world. As of May 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. The healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective and non-essential care.
A survey by the American Cancer Society showed that 50% of cancer patients and survivors reported some impact to their healthcare due to the COVID-19 epidemic.
Read more
A recent survey was conducted by Forbes et al to evaluate the changes in GI and endoscopy practices in North America.
However, the impact of this epidemic on Pulmonology units ( bronchoscopy, thoracoscopy, ultrsonography and sleep lab) globally has not been studied.
- Conditions
- Covid19, Global Impact, Pulmonology
- Being tested
- Survey
- Keywords
- Bronchoscopy, Thoracoscopy, Thoracic ultrasonography, Sleep Lab, Global impact
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
invited questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
global impact of COVID-19 on baseline patients number
number of patients and procedures before and after pandemic
Measured: 6 months
measure the changes in practice in each unit
use of PPE
Measured: 6 months
frequency of SARS-CoV-2 infection in healthcare workers
SARS-CoC-2 infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
- Investigators
- Aliae Mohamed-Hussein, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554251
- Sponsor's protocol ID
- Assiut20
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Impact of COVID-19 on Pulmonology Special Units (Bronchoscopy, Thoracoscopy, Ultrasonography and Sleep Lab)
- ClinicalTrials.gov ID
- NCT04554251
- Acronym / sponsor ID
- Assiut20
- Conditions
- Covid19, Global Impact, Pulmonology
- Keywords
- Bronchoscopy, Thoracoscopy, Thoracic ultrasonography, Sleep Lab, Global impact
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 18 Sep 2020 (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 COVID-19 pandemic is having a profound impact on the world. As of May 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. The healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective and non-essential care.
A survey by the American Cancer Society showed that 50% of cancer patients and survivors reported some impact to their healthcare due to the COVID-19 epidemic.
A recent survey was conducted by Forbes et al to evaluate the changes in GI and endoscopy practices in North America.
However, the impact of this epidemic on Pulmonology units ( bronchoscopy, thoracoscopy, ultrsonography and sleep lab) globally has not been studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- invited pulmonology units; bronchoscopy, thoracoscopy, chest ultrasonography and sleep lab
Key inclusion criteria (1 listed)
- Working registered invited pulmonology units; governmental, university, private
Key exclusion criteria (1 listed)
- non pulmonary medicine registered units
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 |
|---|---|---|
| Surveyinvited questionnaire | Other | – |
Primary outcome
global impact of COVID-19 on baseline patients number
Time frame: 6 months
number of patients and procedures before and after pandemic
measure the changes in practice in each unit
Time frame: 6 months
use of PPE
frequency of SARS-CoV-2 infection in healthcare workers
Time frame: 6 months
SARS-CoC-2 infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Aliae Mohamed-Hussein study chair
Assiut University
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 and Global Impact, 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 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. 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?
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?
global impact of COVID-19 on baseline patients number (time frame: 6 months). The study lists 3 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 18 Sep 2020.