Long Term COVID-19 illness MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Myoquinon 100 mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: UBIDECARENONE
CAS Number: 303-98-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Lars Jørgen Østergaard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 18 years. 2. Able to give informed consent. 3. History of documented SARS-CoV-2 infection either by RT-PCR or antibody test. 4. Symptoms related to LTC, 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. This clinic covers all LTC patients referred from general practitioners and regional hospitals in Region Midtjylland. 5. Symptoms not attributable to other co-morbidity/condition. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Symptoms of acute COVID-19, as defined by The Danish Health Authorities/Sundhedsstyrelsen. 2. Pregnant or breast-feeding women. 3. Known allergy to soy or peanuts. 4. Individuals with reduced kidney or liver-function. 5. Patients in anticoagulant therapy with warfarin or similar vitamin K antagonists. 6. Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 6 weeks of CoQ10 treatment on the number and severity of self-reported symptoms in LTC patients;Secondary Objective: Secondary objectives: -To assess a potential persistent effect of CoQ10 after 6 weeks dosing and 4 weeks of follow-up on the number and severity of self-reported symptoms in LTC patients. -To assess the safety and tolerability of the IMP Potential exploratory objectives: -To investigate occurrence of auto-reactive antibodies at baseline compared to healthy controls (biobank samples). -To assess CoQ10 levels in plasma before and after CoQ10 treatment -To investigate if certain host genetic factors predict LTC -To perform quantitative proteomics of PBMCs by high mass accuracy nanoLC-MS/MS. -To assess cellular metabolic activities by Seahorse analyses of PBMCs samples -To assess oxidative stress in plasma through the marker 8-isoprostane (ELISA). -To assess a panel of cytokines in plasma through antibody based multiplexed analyses. -To assess metabolites of kynurenic pathway in plasma by UPLC-MS/MS. ;Primary end point(s): Number and severity of self-reported symptoms of LTC, measured by self-reporting in questionnaires before and after 6 weeks of CoQ10, measured by symptoms score.;Timepoint(s) of evaluation of this end point: Evaluation of primary endpoint after 6 weeks treatment, 4 weeks washout and 6 weeks placebo (order of intervention determined by allocation by randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of a potential effect of CoQ10 measured as change in symptoms score 2. Safety evaluation, as measured by adverse events (AEs), Adverse Reactions (ARs), serious adverse events (SAEs), Serious ARs (SARs).;Timepoint(s) of evaluation of this end point: 1. 4 weeks after ending IMP: We aim to compare week 6 versus week 10 for study arm A and week 16 versus week 20 for study arm B. 2. Safety will be evaluated at each study visit. Final AE/SAE summary will be completed after 20 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Infectious Diseases
Aarhus University Hospital
Outcome results
None listed