Sponsor study identifier
observational
143
1 country
3
Study Start
January 11, 2021
Actual (reported)Primary Completion
January 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management. A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain. A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients. Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes. The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care. Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2021
Actual (reported)June 21, 2021
Actual (reported)June 25, 2021
Actual (reported)January 1, 2022
Actual (reported)February 1, 2022
Actual (reported)Incidence of secondary chronic pain
Secondary chronic pain as defined by International Classification of Disease -11th revision (ICD-11). Chronic secondary pain is organized into the following six categories: 1. Chronic cancer-related pain (ICD-11 code MG30.1) 2. Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2) 3. Chronic secondary musculoskeletal pain (ICD-11 code MG30.3) 4. Chronic secondary visceral pain (ICD-11 code MG30.4) 5. Chronic neuropathic pain (ICD-11 code MG30.5) 6. Chronic secondary headache or orofacial pain (ICD-11 code MG30.6) Any pain detected in the population of interest and fitting in one of 6 categories will be accounted.
starting 6 month after discharge
Frequency of different secondary chronic pain classes
starting 6 month after discharge
Patients hospitalized to the ICU in the context of severe COVID-19 and discharged alive during the first French COVID-19 pandemic wave
Patient-reported outcomes, listed in the Secondary Outcome Measure Section
Summation pain threshold test and Heat pain threshold skin test
adult patients, infected with SARS COV2 and developed severe COVID, requiring hospitalisation to the ICU during the first French wave of COVID 19, with length of stay \> 48 hours, survived and successfully discharged, and approached from 6th month post discharge.
Hôpital Raymond Poincare - AP-HP
Garches, Hauts-de-Seine, 92380, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
Hopital de la Croix Rousse - Hospices Civils de Lyon
Lyon, 69004, France
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.
Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11.
143 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2021
First Posted
June 25, 2021
Study Start
January 11, 2021
Actual (reported)QST and Neuropathic Pain
Pain sensitivity level
starting 6 month after discharge
Pain localization
starting 6 month after discharge
The severity of pain and its impact on functioning
starting 6 month after discharge
Neuropathic pain
starting 6 month after discharge
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, Chu CM, Wong PC, Tsang KW, Chua SE. Stress and psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 2007 Apr;52(4):233-40. doi: 10.1177/070674370705200405.
Martinez V, Dziadzko M, Tamayo J, Schitter S, Guichard L, Richeux F, Roggerone S, Branche P, Schlaefflin L, Nacto Y, Antunes T, Negre I, Annane D, Aubrun F. Chronic pain characteristics in COVID-19 survivors after an ICU stay. A cross-sectional study. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101267. doi: 10.1016/j.accpm.2023.101267. Epub 2023 Jun 24.
Primary Completion
January 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)Last Updated
February 2, 2022
Record last verified: 2022-02
individual participant data are the property of investigator's centers and will not be shared
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Source: ClinicalTrials.gov.
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