NCT04893070

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

May 11, 2021

Last Update Submit

October 14, 2022

Conditions

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

  • 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).

    18 months after COVID-19 first symptoms

Secondary Outcomes (1)

  • Long-term quality of life (physical component)

    18 months after COVID-19 first symptoms

Study Arms (2)

COVID+

Questionnaires on COVID-19 symptomatology and quality of life

Other: Questionnaires COVID+

COVID-

Questionnaires on quality of life

Other: Questionnaires COVID-

Interventions

* 1 questionnaire on quality of life at enrollment * 1 questionnaire on quality of life 6 months after enrollment

COVID-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • Hospitalized for COVID-19
  • Having received a treatment against COVID-19 (other than paracetamol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1er Centre Médical des Armées

Paris, 75012, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 19, 2021

Study Start

July 15, 2021

Primary Completion

July 4, 2022

Study Completion

July 4, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations