Coenzyme Q10 as Treatment for Long Term COVID-19

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Coenzyme Q10 as Treatment for Long Term COVID-19

Conditions
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Covid19, Long Term Covid19

Intervention / Treatment
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* Drug: Coenzyme Q10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10<br> | Drug: Coenzyme Q10<br>* Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.<br>* Other names: Myoquinon;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A soft gelatin capsule containing soy oil, 5 capsules a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coenzyme Q10