Respiratory FailureNCT05274490
COPD Prognosis in Covid Patients
An observational study of Respiratory Failure, run by Sohag University at 1 site in Egypt.
Trial summary
In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- intubation and mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 2022
- How long will I take part?
- 2 Weeks
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male or female patient more than 20 years old, recently diagnosed covid positive
Who may be able to join
- Age: more than 20 years old.
- Both Males and females will be included.
- COPD patients.
- Recent confirmed the diagnosis with SARS-COV-2.
Who cannot join
- Pregnancy.
- Malignancy.
- Immunodeficiency disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Obstructive Pulmonary Disease Prognosis in Sars-covid 2 Infection
In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate.
- Conditions
- Respiratory Failure
- Being tested
- intubation and mechanical ventilation
- Keywords
- copd, prognosis, covid
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation and mechanical ventilationProcedure or surgery
patients who were in need were intubated and mechanically ventilated
| Study group | Role | What they receive |
|---|---|---|
| copd patients with covid infection | Not described Receives: Procedure: intubation and mechanical ventilation | |
| non-copd patients with covid infection | Not described Receives: Procedure: intubation and mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score measurement in both groups
monitoring of SOFA items along two weeks
Measured: 2 weeks
Secondary outcomes (1)
prognosis of the disease
hospital stay, nedd for mechanical ventilation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274490
- Sponsor's protocol ID
- soh-Med-22-1-26
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2022
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease Prognosis in Sars-covid 2 Infection
- ClinicalTrials.gov ID
- NCT05274490
- Acronym / sponsor ID
- soh-Med-22-1-26
- Conditions
- Respiratory Failure
- Keywords
- copd, prognosis, covid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Mar 2022 (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.
In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| copd patients with covid infection | – | Procedure: intubation and mechanical ventilation |
| non-copd patients with covid infection | – | Procedure: intubation and mechanical ventilation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male or female patient more than 20 years old, recently diagnosed covid positive
Key inclusion criteria (4 listed)
- Age: more than 20 years old.
Key exclusion criteria (3 listed)
- Pregnancy.
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 |
|---|---|---|
| intubation and mechanical ventilationpatients who were in need were intubated and mechanically ventilated | Procedure or surgery | copd patients with covid infection, non-copd patients with covid infection |
Primary outcome
SOFA score measurement in both groups
Time frame: 2 weeks
monitoring of SOFA items along two weeks
1 secondary outcome
prognosis of the disease
Time frame: 2 weeks
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 10 Mar 2022.
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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 Respiratory Failure, run by Sohag 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 4 inclusion and 3 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 10 Mar 2022. 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?
SOFA score measurement in both groups (time frame: 2 weeks). 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 10 Mar 2022.