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Completed

NCT Number: NCT04889313

Post COVID-19 Neurologic Symptoms : a Somatic Spectrum Disorder ? (SOMATiC)

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.

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • patients who were hospitalized during the acute phase of the infection
  • suspected de novo neurological pathology unrelated to COVID-19
  • patient refusal to participate.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Official study title

Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder

Acronym: SOMATiC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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