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Coenzyme Q10 as Treatment for Long Term COVID-19 (QVID)

Primary Purpose

Covid19, Long Term Covid19

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Coenzyme Q10

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Coenzyme Q10

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 11, 2021
Last Updated
May 5, 2022
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Pharma Nord
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1. Study Identification

Unique Protocol Identification Number
NCT04960215
Brief Title
Coenzyme Q10 as Treatment for Long Term COVID-19
Acronym
QVID
Official Title
Coenzyme Q10 as Treatment for Long Term COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Pharma Nord

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Long Term Covid19
Keywords
Coenzyme Q10

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coenzyme Q10
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
Myoquinon
Intervention Description
Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A soft gelatin capsule containing soy oil, 5 capsules a day.
Primary Outcome Measure Information:
Title
Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire.
Description
Number of self-reported symptoms measured by EQ-5D-5L questionnaire.
Time Frame
Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Title
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.
Description
Number of self-reported symptoms measured by Long Term COVID-specific questionnaire.
Time Frame
Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Title
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.
Description
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.
Time Frame
Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Title
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.
Description
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.
Time Frame
Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Secondary Outcome Measure Information:
Title
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.
Description
Number of self-reported symptoms measured by Long Term COVID-specific questionnaire.
Time Frame
Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
Title
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.
Description
Number of self-reported symptoms measured by EQ-5D-5L questionnaire.
Time Frame
Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
Title
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.
Description
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.
Time Frame
Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
Title
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.
Description
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.
Time Frame
Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
Title
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.
Description
Safety evaluation by incidence of adverse events, adverse reactions, serious adverse events and serious adverse reactions.
Time Frame
End of data collection after 20 weeks.
Other Pre-specified Outcome Measures:
Title
Presence of auto-reactive antibodies in Long Term COVID-19
Description
Investigation of auto-reactive antibodies at baseline compared to healthy controls (biobank samples), by immunohistochemistry and enzyme-linked immunosorbent assay (ELISA) against tissue proteins.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment
Title
Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
Description
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.
Time Frame
Blood samples after 6 weeks of treatment and after 6 weeks of placebo.
Title
Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo.
Description
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.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment
Title
Assessment of cellular metabolic activity in PBMCs from Coenzyme Q10 treated patients by Seahorse analysis versus placebo.
Description
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.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment
Title
Analysis of oxidative stress marker 8-isoprostane in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
Description
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.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment
Title
Assessment of presence of cytokines in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
Description
Differential analysis of plasma samples from CoQ10 treated patients versus placebo with Luminex to assess presence of cytokines measured as picomole cytokine / mL.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment
Title
Analysis of metabolites of the kynurenic pathway in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
Description
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.
Time Frame
Blood samples week 6, 10, 16 and 20 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Khalidan Vibholm, M.D., Ph.D
Organizational Affiliation
Department of Infections Diseases, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36337437
Citation
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.
Results Reference
derived

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Coenzyme Q10 as Treatment for Long Term COVID-19

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