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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 |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005961-16/DK |
First author
Last imported at : March 18, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
|
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"}] |