SARS-CoV2 InfectionCOVIDAMBUCMA1NCT04893070
Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population
An observational study of SARS-CoV2 Infection and Covid19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, Covid19
- What is being tested?
- Questionnaires COVID+ and Questionnaires COVID-
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 4 Jul 2022
- 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 is composed of military staff followed at the 1st Centre Médical des Armées (Paris, France) who have suffered from COVID-19 and were managed in ambulatory care (COVID+ group) and who have not been infected by SARS-CoV-2 (COVID- group).
Who may be able to join
- Military personnel
- COVID+: diagnosed with COVID-19 and managed in ambulatory care since March 14th, 2020
- COVID-: not having been infected with SARS-CoV-2
Who cannot join
- Hospitalized for COVID-19
- Having received a treatment against COVID-19 (other than paracetamol)
Trial locations and contacts
1 site in 1 country.
About this study
In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.
- Conditions
- SARS-CoV2 Infection, Covid19
- Being tested
- Questionnaires COVID+, Questionnaires COVID-
- Keywords
- Quality of life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires COVID+Other
- 1 questionnaire on COVID-19 symptomatology and quality of life 12 months after COVID-19 first symptoms
- 1 questionnaire on quality of life 18 months after COVID-19 first symptoms
Questionnaires COVID-Other
- 1 questionnaire on quality of life at enrollment
- 1 questionnaire on quality of life 6 months after enrollment
| Study group | Role | What they receive |
|---|---|---|
| COVID+ | Questionnaires on COVID-19 symptomatology and quality of life Receives: Other: Questionnaires COVID+ | |
| COVID- | Questionnaires on quality of life Receives: Other: Questionnaires COVID- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term quality of life (mental component)
Mental Component Score (MCS) of the SF-36 questionnaire. The MCS ranges from 0 (bad quality of life) to 100 (good quality of life).
Measured: 18 months after COVID-19 first symptoms
Secondary outcomes (1)
Long-term quality of life (physical component)
Physical Component Score (PCS) of the SF-36 questionnaire. The PCS ranges from 0 (bad quality of life) to 100 (good quality of life).
Measured: 18 months after COVID-19 first symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Jul 2021
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 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
- NCT04893070
- Sponsor's protocol ID
- 2020-COVID19-38
- Other IDs
- 2021-A01038-33
- Acronym
- COVIDAMBUCMA1
- Status last verified
- Oct 2022
- First submitted
- 11 May 2021
- Last updated
- 17 Oct 2022
- 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population
- ClinicalTrials.gov ID
- NCT04893070
- Acronym / sponsor ID
- COVIDAMBUCMA1 / 2020-COVID19-38
- Conditions
- SARS-CoV2 Infection, Covid19
- Keywords
- Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 19 May 2021 (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 April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID+ | – | Other: Questionnaires COVID+Questionnaires on COVID-19 symptomatology and quality of life |
| COVID- | – | Other: Questionnaires COVID-Questionnaires on quality of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of military staff followed at the 1st Centre Médical des Armées (Paris, France) who have suffered from COVID-19 and were managed in ambulatory care (COVID+ group) and who have not been infected by SARS-CoV-2 (COVID- group).
Key inclusion criteria (3 listed)
- Military personnel
- COVID+: diagnosed with COVID-19 and managed in ambulatory care since March 14th, 2020
- COVID-: not having been infected with SARS-CoV-2
Key exclusion criteria (2 listed)
- Hospitalized for COVID-19
- Having received a treatment against COVID-19 (other than paracetamol)
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 |
|---|---|---|
| Questionnaires COVID+* 1 questionnaire on COVID-19 symptomatology and quality of life 12 months after COVID-19 first symptoms * 1 questionnaire on quality of life 18 months after COVID-19 first symptoms | Other | COVID+ |
| Questionnaires COVID-* 1 questionnaire on quality of life at enrollment * 1 questionnaire on quality of life 6 months after enrollment | Other | COVID- |
Primary outcome
Long-term quality of life (mental component)
Time frame: 18 months after COVID-19 first symptoms
Mental Component Score (MCS) of the SF-36 questionnaire. The MCS ranges from 0 (bad quality of life) to 100 (good quality of life).
1 secondary outcome
Long-term quality of life (physical component)
Time frame: 18 months after COVID-19 first symptoms
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 17 Oct 2022.
- 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.
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 SARS-CoV2 Infection and Covid19, run by Direction Centrale du Service de Santé des Armées 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 3 inclusion and 2 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 17 Oct 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 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?
Long-term quality of life (mental component) (time frame: 18 months after COVID-19 first symptoms). 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 17 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.