COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8947

Tanja Kuut

moeCOVID@amsterdamumc.nl

2020-10-04

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Long covid

- The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, another positive NAAT test (RT-PCR, LAMP, TMA or mPOCT), positive SARS-CoV-2 serology, a positive Antigen test or CORADS 4 or 5 on CT-scan, - The patient is 3 up to and including 12 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted,- The patient experiences severe levels of fatigue (= 35 on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue]). The severe fatigue started with or increased substantially directly after the onset of symptoms of COVID-19,- The patient reports physical disability (= 65 on the Rand36 physical functioning subscale) and/or social disability (= 10 on the Work and Social Adjustment Scale [WSAS]),- The patient is 18 years of age or older,- The patient has sufficient command of the Dutch language.

- The patient has an already known psychiatric or somatic condition that can explain his/her fatigue. We will also screen for the presence of Post-Traumatic Stress Disorder ([PTSD], (PCL-5) which prevalence may be high in this patient group because of traumatic experiences during the acute phase of COVID-19. We will also screen for the presence of depressive disorder (Mini- International Neuropsychiatric Interview), - The patient currently participates in a multi-disciplinary rehabilitation programme aimed to ameliorate the consequences of COVID-19,- The patient has objectified hypoxemia in rest for which oxygen therapy at home is indicated.

2

Amsterdam University Medical Centers

18

100

Netherlands

Patients recovered from covid

N/A

114

Mean fatigue severity score (CIS-fatigue) across follow-up visits (T1 and T2)

Not reported

[{"arm_notes": "", "treatment_id": 680, "treatment_name": "Internet-based cognitive behavioural therapy", "treatment_type": "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"}]