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Trial - NCT05543590


Column Value
Trial registration number NCT05543590
Full text link
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05543590

First author
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Myriam BENNANI

Contact
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

m.bennani@hopital-europeen.fr

Registration date
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

2022-09-16

Recruitment status
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

inclusion criteria: aged ≥ 18 years who have had confirmed sars-cov2 infection (rt pcr) for at least 6 months having for more than 6 months at least 3 symptoms among the following: fatigue, post effort malaise, dyspnea, headache, diffuse myalgia/arthromyalgia, neuropathic pain, cognitive disorders, anosmia/ageusia whose above symptoms have an impact on daily activities and/or on sick leave for more than 3 months and/or having to take to bed for more than 2 hours a day having given free and informed written consent being affiliated with or benefiting from social security

Exclusion criteria
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

with suspected covid-19 but not confirmed by rt-pcr test having a known history of any other pathology that could be confused with the diagnosis of long covid: multiple sclerosis, autoimmune disease (lupus and gougerot syndrome, inflammatory muscle disease, and myasthenia gravis), untreated hypothyroidism, major depression, use of narcotics regular. unable to perform a cycle ergometer stress test with innate or drug-induced coagulation disorders (oral or parenteral anticoagulation) with contraindications to plasmapheresis such as: lack of peripheral venous access or unstable cardiac pathology pregnant or breastfeeding woman

Number of arms
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Hôpital Européen Marseille

Inclusion age min
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline

Notes
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Sept. 18, 2022, 3 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2337, "treatment_name": "Plasmapheresis", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]