Covid19, Long Term Covid19
Conditions
Keywords
Coenzyme Q10
Brief summary
This study is a randomized, placebo-controlled, double-blinded, cross-over designed clinical trial investigating the effect of high-dose Coenzyme Q10 treatment in subjects with persisting symptoms more than 12 weeks af SARS-CoV-2 infection, Long Term COVID-19 (LTC).
Detailed description
The aim is to investigate the effect of high-dose Coenzyme Q10 on number and severity of self-reported symptoms in patients with Long Term COVID-19. The study will be conducted at the Department of Infectious Diseases, Aarhus University Hospital in the LTC Outpatient Clinic. 120 study participants will be randomized 1:1 to receive placebo or CoQ10 in a dose of 500mg/day for 6 weeks. After a wash-out period of 4 weeks, participants are allocated to the opposite treatment for 6 weeks. The EQ-5D-5L and an LTC-specific questionnaire are completed at baseline and after 6,10,16, and 20 weeks. At each of 5 visits blood samples will be collected from the participants for immunological investigations and assessment of cellular metabolism.
Interventions
DRUGCoenzyme Q10
Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.
DRUGPlacebo
A soft gelatin capsule containing soy oil, 5 capsules a day.
Sponsors
University of Aarhus
Pharma Nord
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years. * Able to give informed consent. * History of documented SARS-CoV-2 infection either by RT-PCR or antibody test. * Symptoms related to Long Term COVID-19, 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. * Symptoms not attributable to other co-morbidity/condition.
Exclusion criteria
* Symptoms of acute COVID-19, as defined by The Danish Health Authorities. * Women who are pregnant or breastfeeding, or with a positive pregnancy test as determined by a positive urine beta-human chorionic gonadotropin test during screening * Hypersensitivity to the active ingredient or to any excipient of the medicinal product * Known allergy to soy or peanuts. * Individuals with reduced kidney or liver-function. * Patients in anticoagulant therapy with vitamin K antagonists. * Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment | Number of self-reported symptoms measured by EQ-5D-5L questionnaire. |
| Effect of Coenzyme Q10 treatment in Long Term COVID-19 on severity (symptoms score) of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment | Severity by symptom score of self-reported symptoms measured by ED-5Q-5L questionnaire. The questionnaire consist of 5 questions with a graduation of 0-4, thus maximum number of points is 20 implying a high number of severe symptoms. |
| Effect of Coenzyme Q10 treatment in Long Term COVID-19 on severity (symptoms score) of self-reported symptoms of LTC measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment | Severity by symptom score of self-reported symptoms measured by Long Term COVID-specific questionnaire. The questionnaire consist of 32 questions with a graduation of 0-4, thus maximum number of points is 128 implying a high number of severe symptoms. |
| Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment | Number of self-reported symptoms measured by Long Term COVID-specific questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. | Number of self-reported symptoms measured by EQ-5D-5L questionnaire. |
| Prolonged effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. | Number of self-reported symptoms measured by Long Term COVID-specific questionnaire. |
| Prolonged effect of Coenzyme Q10 treatment in Long Term COVID-19 on severity (symptoms score) of self-reported symptoms of LTC measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. | Severity by symptom score of self-reported symptoms measured by Long Term COVID-specific questionnaire. The questionnaire consist of 32 questions with a graduation of 0-4, thus maximum number of points is 128 implying a high number of severe symptoms. |
| Prolonged effect of Coenzyme Q10 treatment in Long Term COVID-19 on severity (symptoms score) of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. | Severity by symptom score of self-reported symptoms measured by ED-5Q-5L questionnaire. The questionnaire consist of 5 questions with a graduation of 0-4, thus maximum number of points is 20 implying a high number of severe symptoms. |
| Safety and tolerability of treatment with high-dose Coenzyme Q10 as measured by number of adverse events, adverse reactions, serious adverse events and serious adverse reactions. | End of data collection after 20 weeks. | Safety evaluation by incidence of adverse events, adverse reactions, serious adverse events and serious adverse reactions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of cellular metabolic activity in PBMCs from Coenzyme Q10 treated patients by Seahorse analysis versus placebo. | Blood samples week 6, 10, 16 and 20 after enrollment | Differential analysis of metabolic activities (Seahorse) in PBMCs from the treated patients versus placebo. Extracellular Acidification Rate (ECAR) (picomoles protons / minute) and Oxygen Consumption Rate (OCR) (picomoles O2 per minute) are measured to estimate glycolytic rate and respiration rates in the isolated PBMCs, respectively. |
| Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | Blood samples after 6 weeks of treatment and after 6 weeks of placebo. | Assessment of baseline levels Coenzyme Q10 in plasma (nmol/L) and in PBMC (picogram / mg protein) , measured by High Performance Liquid Chromatography (HPLC), as this parameter previously has been associated with fatigue. |
| Presence of auto-reactive antibodies in Long Term COVID-19 | Blood samples week 6, 10, 16 and 20 after enrollment | Investigation of auto-reactive antibodies at baseline compared to healthy controls (biobank samples), by immunohistochemistry and enzyme-linked immunosorbent assay (ELISA) against tissue proteins. |
| Assessment of presence of cytokines in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | Blood samples week 6, 10, 16 and 20 after enrollment | Differential analysis of plasma samples from CoQ10 treated patients versus placebo with Luminex to assess presence of cytokines measured as picomole cytokine / mL. |
| Analysis of metabolites of the kynurenic pathway in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | Blood samples week 6, 10, 16 and 20 after enrollment | Differential analysis of plasma samples from CoQ10 treated patients versus placebo with respect to metabolites of the kynurenic pathway by LC-MS/MS measured in nanomole per mL. |
| Analysis of oxidative stress marker 8-isoprostane in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | Blood samples week 6, 10, 16 and 20 after enrollment | Differential analysis of plasma samples from CoQ10 treated patients versus placebo, with respect to the oxidative stress marker 8-isoprostane by ELISA assay measured in picomoles 8-isoprostane per mL. |
| Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo. | Blood samples week 6, 10, 16 and 20 after enrollment | Relative quantification of the approximately four thousand most abundant proteins is performed by liquid chromatography (LC) tandem mass spectrometry (MS/MS). The quantitative signal is the MS peak intensities, with arbitrary scale. Statistically differentially regulated proteins are filtered out and described specifically. |
Countries
Denmark
Outcome results
None listed