| Trial registration number
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NCT04842448 |
Full text link
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04842448
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First author
Last imported at : July 15, 2023, midnight
Source : ClinicalTrials.gov
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Anders Kjellberg, MD
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Contact
Last imported at : July 15, 2023, midnight
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-04-13
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Recruitment status
Last imported at : July 15, 2023, midnight
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Long covid
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
aged 18-60 years
healthy or mild systemic disease (asa 1-2) prior to covid-19
symptoms consistent with long covid for at least 12 weeks
diagnosed with long covid, pacs, pcs (icd-10 u09.9)
working or studying prior to covid-19
documented informed consent according to gcp and national regulations
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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known pregnancy or positive pregnancy test in women of childbearing age
asa 3 or more from other cause than long covid
score above 70 in rand-36 role limitation physical health (rp) or physical functioning (pf)
diabetes
diagnosed with hypertension prior to covid-19
contraindication for hyperbaric oxygen treatment according to local guidelines
participation or recent participation in a clinical trial with an investigational product
mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
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Number of arms
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Karolinska University Hospital
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Inclusion age min
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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60
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Countries
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Sweden
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Type of patients
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Patients recovered from covid
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Severity scale
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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80
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primary outcome
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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RAND 36 change
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Notes
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 608, "treatment_name": "Hyperbaric oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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