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Trial - EUCTR2020-005961-16-DK


Column Value
Trial registration number EUCTR2020-005961-16-DK
Full text link
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

First author
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Aarhus University Hospital - Department of Infectious Diseases

Contact
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

KRTHAS@rm.dk

Registration date
Last imported at : July 24, 2021, 9:45 a.m.
Source : EU Clinical Trials Register

2020-12-15

Recruitment status
Last imported at : May 5, 2022, 4 p.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Crossover

Masking
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Long covid

Inclusion criteria
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1. Age above 18 years. 2. Able to give informed consent. 3. History of documented SARS-CoV-2 infection either by RT-PCR or antibody test. 4. Symptoms related to LTC, defined as being investigated, diagnosed and followed by specialized infectious diseases physicians in the Long Term COVID-19 Outpatient Clinic, Central Region of Denmark, Aarhus University Hospital. This clinic covers all LTC patients referred from general practitioners and regional hospitals in Region Midtjylland. 5. Symptoms not attributable to other co-morbidity/condition.

Exclusion criteria
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1. Symptoms of acute COVID-19, as defined by The Danish Health Authorities/Sundhedsstyrelsen. 2. Pregnant or breast-feeding women. 3. Known allergy to soy or peanuts. 4. Individuals with reduced kidney or liver-function. 5. Patients in anticoagulant therapy with warfarin or similar vitamin K antagonists. 6. Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy.

Number of arms
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Lars Jørgen Østergaard

Inclusion age min
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Denmark

Type of patients
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Patients recovered from covid

Severity scale
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

120

primary outcome
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Number and severity of self-reported symptoms of LTC, measured by self-reporting in questionnaires before and after 6 weeks of CoQ10, measured by symptoms score.

Notes
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Declared number of arm (3.0) differs from found arms (2.0)

Phase
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : March 18, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 1326, "treatment_name": "Ubidecarenone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]