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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| Pharma Nord | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme Q10 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 | Drug | Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire. | Number of self-reported symptoms measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment |
| 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. | Number of self-reported symptoms measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment |
| 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. | 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. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment |
| 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. | 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. | Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of self-reported symptoms measured by Long Term COVID-specific questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of auto-reactive antibodies in Long Term COVID-19 | Investigation of auto-reactive antibodies at baseline compared to healthy controls (biobank samples), by immunohistochemistry and enzyme-linked immunosorbent assay (ELISA) against tissue proteins. | Blood samples week 6, 10, 16 and 20 after enrollment |
| Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line Khalidan Vibholm, M.D., Ph.D | Department of Infections Diseases, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases | Aarhus | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36337437 | Derived | Hansen KS, Mogensen TH, Agergaard J, Schiottz-Christensen B, Ostergaard L, Vibholm LK, Leth S. High-dose coenzyme Q10 therapy versus placebo in patients with post COVID-19 condition: a randomized, phase 2, crossover trial. Lancet Reg Health Eur. 2023 Jan;24:100539. doi: 10.1016/j.lanepe.2022.100539. Epub 2022 Nov 2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| Placebo | Drug | A soft gelatin capsule containing soy oil, 5 capsules a day. |
|
| 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. | Number of self-reported symptoms measured by EQ-5D-5L questionnaire. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. |
| 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. | 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. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. |
| 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. | 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. | Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment. |
| 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. | Safety evaluation by incidence of adverse events, adverse reactions, serious adverse events and serious adverse reactions. | End of data collection after 20 weeks. |
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. |
| Blood samples after 6 weeks of treatment and after 6 weeks of placebo. |
| Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo. | 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. | Blood samples week 6, 10, 16 and 20 after enrollment |
| Assessment of cellular metabolic activity in PBMCs from Coenzyme Q10 treated patients by Seahorse analysis versus placebo. | 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. | Blood samples week 6, 10, 16 and 20 after enrollment |
| Analysis of oxidative stress marker 8-isoprostane in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | 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. | Blood samples week 6, 10, 16 and 20 after enrollment |
| Assessment of presence of cytokines in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | Differential analysis of plasma samples from CoQ10 treated patients versus placebo with Luminex to assess presence of cytokines measured as picomole cytokine / mL. | Blood samples week 6, 10, 16 and 20 after enrollment |
| Analysis of metabolites of the kynurenic pathway in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo. | 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. | Blood samples week 6, 10, 16 and 20 after enrollment |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |