NCT04362930

Brief Summary

Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

April 24, 2020

Last Update Submit

February 2, 2024

Conditions

Keywords

COVID-19ENCEPHALOPATHYENCEPHALITISSTROKECONFUSIONDELIRIUMDEPRESSIONPOST TRAUMATIC STRESS DISORDER

Outcome Measures

Primary Outcomes (1)

  • Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19

    Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19

    12 months

Secondary Outcomes (1)

  • Progression of pre-existing neurological or psychiatric pathologies

    12 months

Study Arms (2)

Neurological and psychiatric impact of COVID-19

Covid-19 impact in neurological or psychiatric manifestations in patients with Covid-19 infection

Impact of Covid-19 in patients with neurological pathology

patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection

Eligibility Criteria

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

Patients with Covid-19 infection showing neurological or psychiatric symptoms and patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection

You may qualify if:

  • Age of 18 years or over
  • Patient followed for a neurological or psychiatric pathology OR Patient consulting and presenting a neurological or psychiatric impairment AND
  • Presenting a COVID-19 infection defined by at least one of the following three criteria:
  • Biological diagnosis by any method for direct detection of the virus (Covid-19 positive PCR) or recent infection (serology)
  • Typical chest imaging (CT scan or X-ray) in an epidemic area
  • Clinical-biological data leading to a strong suspicion of current or past Covid-19 infection
  • Non-opposition of the participant, relative or guardian to the research

You may not qualify if:

  • Patient under safety measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Related Publications (1)

  • Pitron V, Cantenys W, Herbelin A, Bottemanne H, Dzierzynski N, Caumes E, Mathian A, Amoura Z, Allenbach Y, Cacoub P, Parrot A, Rotge JY, Fossati P. Factors Associated With Posttraumatic Stress Symptoms 3 and 6 Months After Hospitalization for COVID-19: A Longitudinal Multicenter Study. J Clin Psychiatry. 2022 Dec 7;84(1):21m14277. doi: 10.4088/JCP.21m14277.

Related Links

MeSH Terms

Conditions

Neurologic ManifestationsMental DisordersCOVID-19Brain DiseasesEncephalitisStrokeConfusionDeliriumDepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCentral Nervous System DiseasesNeuroinflammatory DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Design

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

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 27, 2020

Study Start

April 27, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations