This is a multicenter, randomized, placebo controlled, double-blind phase III trial with four parallel groups studying studying the feasibility of RCT in primary care as well as the effectiveness of treatment with prednisolone and/or vitamin B1/6/12 for PC19S.
PC19S affects a considerable portion of patients after an infection with SARS-CoV-2 with a broad range of disabling symptoms. Neurotropic vitamins such as vitamins B1, B6, an B12, and drugs with anti-inflammatory properties such as corticosteroids were suggested to alleviate symptoms. The trial is designed as a two-step approach that will 1. prove the feasibility of recruitment and retention of patients with PC19S in a primary care setting (pilot study, n=100) 2. investigate the effectiveness and safety of the treatment drugs alone and of their combination (confirmatory study, n= 340). The pilot study will be transformed into a confirmatory study if feasibility is given, defined as retention rate of 85% after enrollment of 100 patients. Or on recommendation of the Data Safety and Monitoring Board (DSMB). In addition, blood samples wil be analysed for routine parameters and vitamin B12 derivates as well as cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
321
Administration of prednisolone 20 mg for 5 days, followed by prednisolone 5 mg for 23 days.
Administration of vitamin B compound for 28 days.
Administration of placebo for vitamin B compound placebo for 28 days.
University Hospital Wuerzburg
Würzburg, Bavaria, Germany
Unversity Hospital Schleswig-Holstein
Kiel, Germany
University Hospital Tuebingen
Tübingen, Germany
Pilot phase: Proportion of participants retained after 28 days
feasibility and acceptance of screening and recruitment in primary care; aim \> 85 % retention rate of 100 patients enrolled
Time frame: 4 weeks
Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28
change in symptom severity to day 28 as assessed by specifically tailored total score based on the patient reported outcome measurement information system (PROMIS)
Time frame: 4 weeks
PROMIS total and subscores
Severity of each PC19 symptom domain (patient reported outcome measurement information system (PROMIS))
Time frame: 6 months
Measure Yourself Medical Outcome Profile (MYMOP)
Severity of three subjectively chosen PC19 symptoms
Time frame: 6 months
Overall assessment of functional status
Severity of PC19 symptom burden
Time frame: 6 months
PC19 symptom list
checklist, number of subjectively present symptoms
Time frame: 6 months
EQ-5D-5L
Health related quality of life, 5 point rating scale, 0 to 20 points, higher scores indicate worse outcomes
Time frame: 6 months
visual analogue scale
Health related quality of life, 0 to 100 points, higher scores indicate a better outcome
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Administration of placebo for prednisolone 20 mg for 5 days, followed by placebo for prednisolone 5 mg for 23 days.
Time frame: 6 months
PHQ 8
Depression, 4 point rating scale, 0 to 24 points possible, higher scores indicate a worse outcome
Time frame: 6 months
Chalder Scale
Fatigue, 4 point rating scale, 0 to 33 points possible, higher values indicate a worse outcome
Time frame: 6 months
Numeric rating scale for pain
Pain, 10 point rating scale, higher values indicate a worse outcome
Time frame: 6 months
Testbatterie zur Aufmerksamkeitsprüfung (TAP)
cognitive function (Alertness: reaction time, distractibility: omissions and reaction time, divided attention: omissions, visual scanning: omissions and reaction time, flexibility: reaction time and errors)
Time frame: 4 weeks
Physical exercise
1minute Sit-to-Stand-Test, number of repetitions, BORG Scale, oxygen-saturation
Time frame: 6 months
Use of on-demand medication and change in concomitant medication
intake of on-demand medication, daily drug doses
Time frame: 6 months
qualitative assessment of acceptance
qualitative interviews with subgroup sample
Time frame: 6 months
feasibility/acceptance
exploratory questionnaire, rating scales and grades
Time frame: 6 months