NCT05200832

Brief Summary

Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%). These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care. The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

January 19, 2022

Last Update Submit

September 12, 2022

Conditions

Keywords

quality of lifelong COVID

Outcome Measures

Primary Outcomes (1)

  • Prevalence of mental health events

    Prevalence of mental health events will be calculated in each group, the compared: number of participants who report having experienced a mental health event (e.g. anxiety disorder) divided by the number of participants.

    Until the end of the study (12 months)

Study Arms (2)

COVID+

Participants who have experienced COVID-19

Other: Online questionnaireOther: Semi-structured interview

COVID-

Participants who have not experienced COVID-19

Other: Online questionnaireOther: Semi-structured interview

Interventions

Participants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic.

COVID+COVID-

20 participants (10 from each group) will be randomly selected to participate in a semi-structured interview focusing on their perception of their health and quality of life since the start of the pandemic.

COVID+COVID-

Eligibility Criteria

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

The study population will be composed of people affiliated to the French military health insurance, i.e., military Personnel (active or retired) and their families.

You may qualify if:

  • Age ≥ 18 years-old
  • Be affiliated to the French military health insurance

You may not qualify if:

  • Age \< 18 years-old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Epidémiologie et de Santé Publique des Armées

Marseille, 13014, France

RECRUITING

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 21, 2022

Study Start

September 5, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations