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

Covid19 Clinical Trial

— COVIDAMBUCMA1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893070
• Other study ID #: 2020-COVID19-38
• Secondary ID: 2021-A01038-33
• Status: Completed
• Start date: July 15, 2021
• Est. completion date: July 4, 2022

Study information

• Verified date: October 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 4, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• SARS-CoV2 Infection

Intervention

Other:
• 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
• Questionnaires COVID-
1 questionnaire on quality of life at enrollment 1 questionnaire on quality of life 6 months after enrollment

Locations

Country	Name	City	State
France	1er Centre Médical des Armées	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	18 months after COVID-19 first symptoms