COVID-19 Respiratory InfectionNCT05607069
Multifactorial Evaluation of COVID-19 Respiratory Reliquates
An observational study of COVID-19 Respiratory Infection, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2022to 28 May 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients scheduled for lung resection surgery that had a documented previous SARS-Cov2 infection.
Who may be able to join
- previous SARS-Cov2 infection
- awaiting lung resection surgery
Who cannot join
- less than 18 years of age
- unable to consent to enroll
- refuse to enroll
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Turin, 10100
Luca Brazzi, PhD, +39 011 6335501, luca.brazzi@unito.it
Irene Steinberg, MD, irene@steinberg.it
About this study
The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. In particular, the investigators will gather information concerning imaging (lung ct and lung ultrasound), arterial blood gas analysis, and pulmonary function tests.
- Conditions
- COVID-19 Respiratory Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 previous infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensibility of preoperative evaluation in identifying pathological sequelae due to SARS-Cov2 infection
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start28 May 2022
- Primary completion28 May 2023
- Study completion28 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607069
- Sponsor's protocol ID
- 00097/2022
- Status last verified
- Jul 2023
- First submitted
- 4 Nov 2022
- Last updated
- 2 Aug 2023
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Evaluation of COVID-19 Respiratory Reliquates
- ClinicalTrials.gov ID
- NCT05607069
- Acronym / sponsor ID
- 00097/2022
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 28 May 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 7 Nov 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.
The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. In particular, the investigators will gather information concerning imaging (lung ct and lung ultrasound), arterial blood gas analysis, and pulmonary function tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 previous infection | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients scheduled for lung resection surgery that had a documented previous SARS-Cov2 infection.
Key inclusion criteria (2 listed)
- previous SARS-Cov2 infection
- awaiting lung resection surgery
Key exclusion criteria (3 listed)
- less than 18 years of age
- unable to consent to enroll
- refuse to enroll
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
sensibility of preoperative evaluation in identifying pathological sequelae due to SARS-Cov2 infection
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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.
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 Respiratory Infection, run by University of Turin, Italy at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensibility of preoperative evaluation in identifying pathological sequelae due to SARS-Cov2 infection (time frame: 12 month). 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 Aug 2023.