Neuromuscular DiseasesVA-C-NEMUSNCT05311904
Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients
An observational study of Neuromuscular Diseases, run by University Hospital, Bordeaux at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Survey
- How many people
- 1,388 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2021to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a neuromuscular disease
Who may be able to join
- 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.)
Show all 19Show fewer
- 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
- Other myopathies with confirmed genetic diagnosis
- Patient over 18 years old
- Patient having understood that the follow-up of a possible side effect of the vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by the observatory team Va-C-NEMUS
- Patients having been informed of the study and having expressed their agreement
Who cannot join
- 1. Patient under legal protection, curatorship or tutorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients
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.
Read the detailed description
Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is eagerly awaited by patients and their healthcare teams. An unprecedented research effort has made it possible to create vaccines in a very short time when no vaccine directed against a coronavirus has existed until now. Some of these vaccines are based on proven technologies while others such as RNA vaccines are very innovative. The results of the phase III studies of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the European Medicines Agency. The data on the individuals enrolled in these trials are still not very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data from 4 different trials. In two of them the patients had to be in "good health". In any case, we do not know the pathologies presented by patients outside the usual risk factors for the severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No data on neuromuscular patients are currently known. The vaccination campaign began in France in January 2021. The first neuromuscular patients should be vaccinated soon depending on their comorbidities, but many questions arise in these patients both in terms of safety and efficacy.
- Conditions
- Neuromuscular Diseases
- Being tested
- Survey
- Keywords
- COVID-19, vaccination, safety
- Medical subject headings
- Neuromuscular Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Frequency of Adverse Effects (AEs) in the population of neuromuscular patients vaccinated against COVID19
Measured: 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
Myasthenia Gravis Foundation of America classification
Measured: 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
Frequency of worsening of the MG-ADL activity score by more than 2 points between the week before vaccination and the week following vaccination will be evaluated The Myasthenia Gravis-specific Activities of Daily Living scale consists of the assessment of 8 parameters: speaking, chewing, swallowing, breathing, self-care activities (brushing the teeth or combing the hair), simple physical activities (getting up from a chair), double vision and eye lid dropping. Each parameter is subjected to assessment depending on the degree of symptoms intensification, awarding points from 0 to 3 points. The maximum number a patient may receive is 24 points. The higher the score of points, the bigger limitations of the patient in everyday life activities caused by intensification of myasthenia gravis (Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology 1999;52:1487-1489.)
Measured: 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
Frequency of hospitalizations for myasthenic crisis in the month following vaccination
Measured: 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
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test
Measured: at least 7 days after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: 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
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring
Measured: at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 2 months
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.
Measured: at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 3 months
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.
Measured: at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 4 months
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.
Measured: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 5 months
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.
Measured: at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 6 months
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.
Measured: at 6 months 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) at 2 months
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
Measured: at 2 months 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) at 3 months
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
Measured: at 3 months 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) at 4 months
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
Measured: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of unexepected adverse reactions (SUSARs) at 5 months
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
Measured: at 5 months 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) at 6 months
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
Measured: at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 Mar 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guilhem SOLE, MD, Principal investigator, Université Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311904
- Sponsor's protocol ID
- CHUBX 2020/68
- Acronym
- VA-C-NEMUS
- Status last verified
- Oct 2023
- First submitted
- 31 Mar 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT05311904
- Acronym / sponsor ID
- VA-C-NEMUS / CHUBX 2020/68
- Conditions
- Neuromuscular Diseases
- Keywords
- COVID-19, vaccination, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is eagerly awaited by patients and their healthcare teams. An unprecedented research effort has made it possible to create vaccines in a very short time when no vaccine directed against a coronavirus has existed until now. Some of these vaccines are based on proven technologies while others such as RNA vaccines are very innovative. The results of the phase III studies of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the European Medicines Agency. The data on the individuals enrolled in these trials are still not very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data from 4 different trials. In two of them the patients had to be in "good health". In any case, we do not know the pathologies presented by patients outside the usual risk factors for the severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No data on neuromuscular patients are currently known. The vaccination campaign began in France in January 2021. The first neuromuscular patients should be vaccinated soon depending on their comorbidities, but many questions arise in these patients both in terms of safety and efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a neuromuscular disease
Key inclusion criteria (19 listed)
- Patient with one of the following neuromuscular diseases:
- Patient over 18 years old
- Patient having understood that the follow-up of a possible side effect of the vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by the observatory team Va-C-NEMUS
- Patients having been informed of the study and having expressed their agreement
Key exclusion criteria (1 listed)
- 1. Patient under legal protection, curatorship or tutorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months | Other | – |
Primary outcome
the frequency of serious adverse reactions (SAEs)
Time frame: 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 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.
the frequency of unexpected adverse reactions (SUSARs)
Time frame: at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
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
21 secondary outcomes
vaccination's global safety : Frequency of Adverse Effects (AEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at least 7 days after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Time frame: 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
Time frame: at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Time frame: at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Time frame: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Time frame: at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
effectiveness of the vaccination
Time frame: at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 2 months
Time frame: at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 3 months
Time frame: at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 4 months
Time frame: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 5 months
Time frame: at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) at 6 months
Time frame: at 6 months 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) at 2 months
Time frame: at 2 months 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) at 3 months
Time frame: at 3 months 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) at 4 months
Time frame: at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of unexepected adverse reactions (SUSARs) at 5 months
Time frame: at 5 months 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) at 6 months
Time frame: at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilhem SOLE, MD principal investigator
Université Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of serious adverse reactions (SAEs) (time frame: at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.