High-dose coenzyme Q10 therapy versus placebo in patients with post COVID-19 condition: A randomized, phase 2, crossover trial

Kristoffer S. Hansen*, Trine H. Mogensen, Jane Agergaard, Berit Schiøttz-Christensen, Lars Østergaard, Line K. Vibholm, Steffen Leth

*Kontaktforfatter

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Abstract

Background: Post COVID-19 condition (PCC) is defined as symptoms lasting more than 12 weeks after developing COVID-19. Evidence of mitochondrial dysfunction has been reported in peripheral blood mononuclear cells obtained from patients with COVID-19. We hypothesized that PCC is caused by prolonged mitochondrial dysfunction. Given that coenzyme Q10 (CoQ10) can improve mitochondrial function, we examined whether high-dose CoQ10 can reduce the number and/or severity of PCC-related symptoms. Methods: In this placebo-controlled, double-blind, 2 × 2 crossover interventional trial, participants were recruited from two centres at Aarhus University Hospital and Gødstrup Hospital, Denmark. They were randomly assigned to receive either oral capsules of CoQ10 in a dose of 500 mg/day or placebo for 6 weeks, with crossover treatment after a 4-week washout period. The ED-5Q and a PCC-symptom specific questionnaire were completed by the participants at 5 visits during the 20-week study period. The primary endpoint was the change in the number and/or severity of PCC-related symptoms after the 6-week intervention compared to placebo. Participants who completed the two-dosing period were included in the primary analysis, while all participants receiving one dose were included in safety assessment. Findings: From May 25th, 2021, to September 22nd, 2021, 121 participants underwent randomization, and 119 completed both dosing periods – 59 and 60 in group A and B, respectively. At baseline, the mean PCC-related symptom score was 43.06 (95% CI: 40.18; 45.94), and the mean EQ-5D health index was 0.66 (95% CI: 0.64; 0.68). The difference between CoQ10 and placebo was not significant with respect to either the change in EQ-5D health index (with a mean difference of 0.01; 95% CI: −0.02; 0.04; p = 0.45) or the change in PCC-related symptom score (with a mean difference of −1.18; 95% CI: −3.54; 1.17; p = 0.32). Interpretation: Based on self-reported data, CoQ10 treatment does not appear to significantly reduce the number or severity of PCC-related symptoms when compared to placebo. However, we observed a significant spontaneous improvement on both scores regardless of treatment during 20 weeks observation. Funding: Placebo and CoQ10 capsules were provided by Pharma Nord, and the trial was supported by grants from the Novo Nordisk Foundation (NNF21OC0066984). This trial is registered with EudraCT, 2020-005961-16 and ClinicalTrials.gov, NCT04960215. The trial is completed.

OriginalsprogEngelsk
Artikelnummer100539
TidsskriftThe Lancet Regional Health - Europe
Vol/bind24
ISSN2666-7762
DOI
StatusUdgivet - jan. 2023

Bibliografisk note

Funding Information:
Placebo and CoQ10 capsules were provided by Pharma Nord, and the trial was supported by grants from the Novo Nordisk Foundation (NNF21OC0066984). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Funding Information:
Novo Nordisk Foundation (NNF21OC0066984) and PharmaNord funded this study. We thank our project nurses Yordanos Yehdego, Ane Søndergaard, and Malene Østergaard; we are particularly grateful to nurse Sandra Schieber for assistance administering the investigational drugs and for logistical assistance. We thank physicians Nina Breinholt Stærke and Vibeke Klastrup for their assistance with the study visits. We also thank Johan Palmfeldt and Rikke Katrine Jentoft Olsen for their assistance in selection of therapy. Finally, we thank the MULTICOV Study Group.

Publisher Copyright:
© 2022 The Author(s)

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