Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients

NCT05311904 | Completed

• 1 other identifier: CHUBX 2020/68
• Study Type: observational
• Target: 1,388
• Locations: 1 country
• Sites: 1

Brief Summary

The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and in severe cases and long hospital stays, the disability of some neuromuscular patients may worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as myasthenia gravis can worsen after an infection such as COVID-19. Thanks to an unprecedented research effort, vaccines are now available and others still in development. The first studies published in medical journals are reassuring about the efficacy and safety of these vaccines. However, they have been studied in the general population and we do not yet have specific information in neuromuscular patients. This is the reason why the Va-C-NEMUS observatory was launched.

Conditions

Neuromuscular Diseases

Keywords

COVID-19; vaccination; safety

Outcome Measures

Primary Outcomes (2)

• the frequency of serious adverse reactions (SAEs)

  the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline) Any adverse reaction or event that: * results in death, * endangers the life of the participant, * requires hospitalisation or prolongation of hospitalisation, * causes an inability or significant or long-term disability, * results in an abnormality or congenital malformation, * or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

• the frequency of unexpected adverse reactions (SUSARs)

  Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

Secondary Outcomes (21)

• vaccination's global safety : Frequency of Adverse Effects (AEs)

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

• Risk of worsening autoimmune myasthenia gravis after vaccination

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

• Frequency of worsening of the autonomy of the patients evaluated with the MG-ADL

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

• Frequency of hospitalizations for myasthenic crisis

  at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

• effectiveness of the vaccination

  at least 7 days after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).

Interventions

Survey OTHER

1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a neuromuscular disease

You may qualify if:

• Patient with one of the following neuromuscular diseases:
• Autoimmune myasthenia gravis, Lambert-Eaton syndrome
• Congenital myasthenic syndromes
• Myositis
• Inflammatory neuropathies
• Hereditary neuropathies (Charcot-Marie-Tooth disease, etc.)
• Amyloid neuropathies
• Spinal atrophies
• Myotonic dystrophies type 1 (Steinert disease) and 2 (PROMM)
• Duchenne and Becker muscular dystrophies
• Muscular dystrophies of the girdles
• Pump disease
• Congenital myopathies
• Congenital muscular dystrophies
• Metabolic myopathies

You may not qualify if:

• \. Patient under legal protection, curatorship or tutorship

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases; COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guilhem SOLE, MD

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2022
• Study Start: March 11, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

FR (1)