Clinical Practice During the COVID-19 CrisisNCT04476823
European Pathology Laboratories and COVID-19
An observational study of Clinical Practice During the COVID-19 Crisis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Practice During the COVID-19 Crisis
- What is being tested?
- Activity
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2020to 31 May 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: Pathology laboratories belonging to the Lung working group of the European Society of Pathology and to additional European pathology laboratories expert in thoracic diseases
Who may be able to join
- laboratories following the COVID-19 crisis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.
The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.
- Being tested
- Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivityOther
The questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members.
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity
The activity of the pathology laboratories has been compared for a same period (from the 15th of March 15 to the 31th of May) in 2019 and in 2020
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Practice During the COVID-19 CrisisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476823
- Sponsor's protocol ID
- 20labocovid01
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 20 Jul 2020
- 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04476823
- Acronym / sponsor ID
- 20labocovid01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 20 Jul 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 infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathology laboratories belonging to the Lung working group of the European Society of Pathology and to additional European pathology laboratories expert in thoracic diseases
Key inclusion criteria (1 listed)
- laboratories following the COVID-19 crisis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ActivityThe questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members. | Other | – |
Primary outcome
Activity
Time frame: 1 day
The activity of the pathology laboratories has been compared for a same period (from the 15th of March 15 to the 31th of May) in 2019 and in 2020
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 20 Jul 2020.
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 Clinical Practice During the COVID-19 Crisis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 0 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 20 Jul 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 France. 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?
Activity (time frame: 1 day). 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 20 Jul 2020.