COVID-19SOMATiCNCT04889313
Post COVID-19 Neurologic Symptoms : a Somatic Spectrum Disorder ? (SOMATiC)
An observational study of COVID-19, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients referred for neurology consultation to a referent neurologist in our center from may 2020 to may 2021
Who may be able to join
- adults (18 years-old or older)
- having had a mild or moderate COVID-19 managed on an outpatient basis during the acute phase of the infection
- COVID-19 virologically confirmed or suspected on the basis of suggestive symptoms
- spontaneously consulting for post-COVID-19 symptoms and referred for neurological advice in our center
- with neurological clinical evaluation concluding that there is no differential diagnosis.
Who cannot join
- patients who were hospitalized during the acute phase of the infection
- suspected de novo neurological pathology unrelated to COVID-19
- patient refusal to participate.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier de Saint-Denis
Saint-Denis, Île-de-France Region, 93200
About this study
Official title: Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms.
Read the detailed description
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms. The study includes consecutive patients referred for neurology consultation because of chronic neurologic symptoms after the acute phase of COVID-19. Data are collected with medical record and by phone interview. It consisted of a semi-structured interview followed by hetero-assessed scales. A positive diagnosis of SSD was established with all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C. To complete the DSMV criteria, the investigators assessed the presence of indirect argument in favor of SSD diagnosis : a traumatic experience of the initial episode collected during the interview, post-traumatic stress disorder measured by the IES-R scale, a psychiatric history collected during the interview, significant alexithymia measured by the TAS 20 scale, traits of pronounced perfectionism with the scale adapted by Cox et al. from HF MPS, chronic fatigue syndrome as described after viral infections with the SOFA scale, functional disorders prior to infection with SARS-CoV-2, a former and/or current medical nomadism, a significant consumption of care. The quality of life is measured by the WHOQOL-BREF scale, anxious and/or depressive symptoms measured by the HAD scale, and sleep disorders assessed by the ISI scale .
- Conditions
- COVID-19
- Keywords
- Somatic Symptom Disorder, COVID-19, Neurologic symptoms
- Medical subject headings
- COVID-19, Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
A positive diagnosis of SSD
all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start22 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889313
- Sponsor's protocol ID
- CHSD_NEURO_01
- Acronym
- SOMATiC
- Status last verified
- Feb 2022
- First submitted
- 14 May 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kachaner A, Lemogne C, Dave J, Ranque B, de Broucker T, Meppiel E. Somatic symptom disorder in patients with post-COVID-19 neurological symptoms: a preliminary report from the somatic study (Somatic Symptom Disorder Triggered by COVID-19). J Neurol Neurosurg Psychiatry. 2022 Aug 25:jnnp-2021-327899. doi: 10.1136/jnnp-2021-327899. Online ahead of print.
PubMed 36008115
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04889313
- Acronym / sponsor ID
- SOMATiC / CHSD_NEURO_01
- Conditions
- COVID-19
- Keywords
- Somatic Symptom Disorder, COVID-19, Neurologic symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 May 2021 (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.
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms.
Detailed description
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms. The study includes consecutive patients referred for neurology consultation because of chronic neurologic symptoms after the acute phase of COVID-19. Data are collected with medical record and by phone interview. It consisted of a semi-structured interview followed by hetero-assessed scales. A positive diagnosis of SSD was established with all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C. To complete the DSMV criteria, the investigators assessed the presence of indirect argument in favor of SSD diagnosis : a traumatic experience of the initial episode collected during the interview, post-traumatic stress disorder measured by the IES-R scale, a psychiatric history collected during the interview, significant alexithymia measured by the TAS 20 scale, traits of pronounced perfectionism with the scale adapted by Cox et al. from HF MPS, chronic fatigue syndrome as described after viral infections with the SOFA scale, functional disorders prior to infection with SARS-CoV-2, a former and/or current medical nomadism, a significant consumption of care. The quality of life is measured by the WHOQOL-BREF scale, anxious and/or depressive symptoms measured by the HAD scale, and sleep disorders assessed by the ISI scale .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients referred for neurology consultation to a referent neurologist in our center from may 2020 to may 2021
Key inclusion criteria (5 listed)
- adults (18 years-old or older)
- having had a mild or moderate COVID-19 managed on an outpatient basis during the acute phase of the infection
- COVID-19 virologically confirmed or suspected on the basis of suggestive symptoms
- spontaneously consulting for post-COVID-19 symptoms and referred for neurological advice in our center
- with neurological clinical evaluation concluding that there is no differential diagnosis.
Key exclusion criteria (3 listed)
- patients who were hospitalized during the acute phase of the infection
- suspected de novo neurological pathology unrelated to COVID-19
- patient refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A positive diagnosis of SSD
Time frame: 30 minutes
all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C
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 10 Feb 2022.
- Derived from this study: PubMed 36008115Kachaner A, Lemogne C, Dave J, Ranque B, de Broucker T, Meppiel E. Somatic symptom disorder in patients with post-COVID-19 neurological symptoms: a preliminary report from the somatic study (Somatic Symptom Disorder Triggered by COVID-19). J Neurol Neurosurg Psychiatry. 2022 Aug 25:jnnp-2021-327899. doi: 10.1136/jnnp-2021-327899. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by Centre Hospitalier de Saint-Denis 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 5 inclusion and 3 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 10 Feb 2022. 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?
A positive diagnosis of SSD (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889313, which also lists 1 linked publication.
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 10 Feb 2022.