Coenzyme Q10 as treatment for Long Term COVID-19

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Autores
Categoria Primary study
Registry of TrialsEU Clinical Trials Register
Year 2021
INTERVENTION: 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 number: 100‐ Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: Long Term COVID‐19 illness ; MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID‐19 System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Body processes [G] ‐ Cell Physiological Phenomena [G04] PRIMARY OUTCOME: Main Objective: To assess the effect of 6 weeks of CoQ10 treatment on the number and severity of self‐reported symptoms in LTC patients 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. 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.; 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 OUTCOME: 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 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
Epistemonikos ID: e1bc61329f713bfbb47664df6a8a4c83a1d1a356
First added on: Mar 23, 2021