Covid19CovaéNCT04514874
Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
An observational study of Covid19 and SARS-CoV Infection, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
Trial summary
The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Questionnaire
- How many people
- 479 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 31 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of professional military aircrew of all aeronautical specialties presenting themselves for a periodic medical exam.
Who may be able to join
- At least 18 years of age
- Professional military aircrew
- Presenting himself/herself for a periodic medical exam
Who cannot join
- Under 18 years of age
- Parachutists
- Non-professional aircrew
- Presenting himself/herself for a first medical exam
- Pregnant woman, parturient, breastfeeding
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Percy
Clamart, 92140
Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
About this study
The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self-questionnaire about socio-demographical status, health status and lifestyle habits during and following the COVID-19 pandemic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID-19 infection among French military professional aircrew
Prevalence of COVID-19 infection will be estimated on the basis of the replies to the questionnaire
Measured: At enrollment
Secondary outcomes (7)
Predictive factors of COVID-19 infection
Predictive factors of COVID-19 infection will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.
Measured: At enrollment
Techniques used for COVID-19 screening
Techniques used for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)
Measured: At enrollment
Reasons for COVID-19 screening
Reasons for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)
Measured: At enrollment
Experienced symptoms of COVID-19
Experienced symptoms of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)
Measured: At enrollment
Medical care of COVID-19
Medical care of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)
Measured: At enrollment
Social consequences of the COVID-19 pandemic
Social consequences of the COVID-19 pandemic will be estimated on the basis of the replies to the questionnaire
Measured: At enrollment
Factors associated with pejorative consequences of the COVID-19 pandemic
Factors associated with pejorative consequences of the COVID-19 pandemic will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- 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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514874
- Sponsor's protocol ID
- 2020-COVID19-26
- Other IDs
- 2020-A01459-30
- Acronym
- Covaé
- Status last verified
- May 2023
- First submitted
- 14 Aug 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
- ClinicalTrials.gov ID
- NCT04514874
- Acronym / sponsor ID
- Covaé / 2020-COVID19-26
- Conditions
- Covid19, SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Aug 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 aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of professional military aircrew of all aeronautical specialties presenting themselves for a periodic medical exam.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Professional military aircrew
- Presenting himself/herself for a periodic medical exam
Key exclusion criteria (5 listed)
- Under 18 years of age
- Parachutists
- Non-professional aircrew
- Presenting himself/herself for a first medical exam
- Pregnant woman, parturient, breastfeeding
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 |
|---|---|---|
| QuestionnaireSelf-questionnaire about socio-demographical status, health status and lifestyle habits during and following the COVID-19 pandemic. | Other | – |
Primary outcome
Prevalence of COVID-19 infection among French military professional aircrew
Time frame: At enrollment
Prevalence of COVID-19 infection will be estimated on the basis of the replies to the questionnaire
7 secondary outcomes
Predictive factors of COVID-19 infection
Time frame: At enrollment
Techniques used for COVID-19 screening
Time frame: At enrollment
Reasons for COVID-19 screening
Time frame: At enrollment
Experienced symptoms of COVID-19
Time frame: At enrollment
Medical care of COVID-19
Time frame: At enrollment
Social consequences of the COVID-19 pandemic
Time frame: At enrollment
Factors associated with pejorative consequences of the COVID-19 pandemic
Time frame: At enrollment
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 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 SARS-CoV Infection, run by Direction Centrale du Service de Santé des Armées at 2 sites 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 3 inclusion and 5 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence of COVID-19 infection among French military professional aircrew (time frame: At enrollment). 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 May 2023.