Coenzyme Q10 as Treatment for Long Term COVID-19

Covid19 Clinical Trial

— QVID  

Official title:

Coenzyme Q10 as Treatment for Long Term COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960215
• Other study ID #: QVID-001
• Status: Completed
• Phase: Phase 2
• Start date: May 25, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: June 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Coenzyme Q10
Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.
• Placebo
A soft gelatin capsule containing soy oil, 5 capsules a day.

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases	Aarhus	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Pharma Nord, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus 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.	Blood samples after 6 weeks of treatment and after 6 weeks of placebo.
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.