COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04466800

Lilian Alix

Not reported

2020-07-10

Completed

RCT

Randomized

Parallel

Open label

multi-center

Long covid

inclusion criteria: - age above 18 years - laboratory (rt-pcr and/or serology) confirmed infection with sars-cov-2 - date of first symptoms of sars-cov-2 infection > 4 weeks and < 4 months - persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after covid, defined as : - increase of mmrc (modified medical research council) score ≥ 1 between the month before covid and beyond the first 4 weeks after covid and/or - asthenia score (pichot asthenia scale) > 22 beyond the first 4 weeks after covid, if patient had no asthenia before covid (asthenia score <8) and/or - weight loss > 5% within 6 months, comparing minimum weight between the month before covid and beyond the first 4 weeks after covid and/or - bmi (body mass index) < 20 (if age < 70 years) or < 22 (if age ≥ 70 years) if bmi (body mass index) ≥ 20 (if age < 70 years) or ≥ 22 (if age ≥ 70 years) the month before covid - patient affiliated to social security system - patient gave written informed consent

- patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia - patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program - patient living in a residential facility for dependent elderly people - patient not speaking french - pregnant women

2

Rennes University Hospital

18

100

France

Patients recovered from covid

N/A

160

Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life

None

Not reported

[{"arm_notes": "Regular physical activity, systematic malnutrition screening and a nutritional follow-up performed by a dietetician", "treatment_id": 1666, "treatment_name": "Nutritional follow-up+physical exercises", "treatment_type": "Nutrition+rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]