Clinical trial NCT04960215: Coenzyme Q10 as Treatment for Long Term COVID-19
Official title: Coenzyme Q10 as Treatment for Long Term COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Long Term Covid19
Keywords: Coenzyme Q10
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Pharma Nord
First posted: 2021-07-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire.
timeFrame: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Secondary outcomes:
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
measure: 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.
timeFrame: Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.
measure: 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.
timeFrame: End of data collection after 20 weeks.
Other outcomes:
measure: Presence of auto-reactive antibodies in Long Term COVID-19
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
measure: Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
timeFrame: Blood samples after 6 weeks of treatment and after 6 weeks of placebo.
measure: Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo.
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
measure: Assessment of cellular metabolic activity in PBMCs from Coenzyme Q10 treated patients by Seahorse analysis versus placebo.
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
measure: Analysis of oxidative stress marker 8-isoprostane in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
measure: Assessment of presence of cytokines in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
measure: Analysis of metabolites of the kynurenic pathway in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.
timeFrame: Blood samples week 6, 10, 16 and 20 after enrollment
Locations:
city: Aarhus
country: Denmark
facility: Department of Infectious Diseases
state: Aarhus N
Study officials:
affiliation: Department of Infections Diseases, Aarhus University Hospital
name: Line Khalidan Vibholm, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.