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OpenTrials
Completed

NCT Number: NCT04893070

Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1er Centre Médical des Armées

Paris, 75012, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Long-term quality of life (physical component)

    Time frame: 18 months after COVID-19 first symptoms

    Physical Component Score (PCS) of the SF-36 questionnaire. The PCS ranges from 0 (bad quality of life) to 100 (good quality of life).

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: COVIDAMBUCMA1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2021
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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