Skip to main content
OpenTrials
Completed

NCT Number: NCT04960215

Coenzyme Q10 as Treatment for Long Term COVID-19

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Long Term Covid19 Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Infectious Diseases

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coenzyme Q10

Drug

Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.

Other names: Myoquinon

Placebo

Drug

A soft gelatin capsule containing soy oil, 5 capsules a day.

Primary outcomes

  1. Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire.

    Time frame: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment

    Number of self-reported symptoms measured by EQ-5D-5L questionnaire.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.

    Number of self-reported symptoms measured by EQ-5D-5L questionnaire.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. 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.

    Time frame: End of data collection after 20 weeks.

    Safety evaluation by incidence of adverse events, adverse reactions, serious adverse events and serious adverse reactions.

Other outcomes

  1. Presence of auto-reactive antibodies in Long Term COVID-19

    Time frame: 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.

  2. Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.

    Time frame: 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.

  3. Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo.

    Time frame: 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.

  4. Assessment of cellular metabolic activity in PBMCs from Coenzyme Q10 treated patients by Seahorse analysis versus placebo.

    Time frame: 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.

  5. Analysis of oxidative stress marker 8-isoprostane in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.

    Time frame: 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.

  6. Assessment of presence of cytokines in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.

    Time frame: 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.

  7. Analysis of metabolites of the kynurenic pathway in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Pharma Nord
  • University of Aarhus

Registry information

Acronym: QVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.