Coenzyme Q10 as Treatment for Long Term COVID-19

NCT04960215 | Completed Phase 2 DMC

• 1 other identifier: QVID-001
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; Long Term Covid19

Keywords

Coenzyme Q10

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• 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.

  Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.

• 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.

  Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.

• 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.

  Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.

• 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.

  Changes from baseline questionnaire response to questionnaire response 4 weeks after ended treatment.

• 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.

  End of data collection after 20 weeks.

Other Outcomes (7)

• Presence of auto-reactive antibodies in Long Term COVID-19

  Blood samples week 6, 10, 16 and 20 after enrollment

• Assessment of levels of Coenzyme Q10 plasma and PBMC in Long Term COVID-19 patients treated with Coenzyme Q10 versus placebo.

  Blood samples after 6 weeks of treatment and after 6 weeks of placebo.

• Quantitative proteomics in peripheral blood mononuclear cells (PBMCs) from Coenzyme Q10 treated patients versus placebo.

  Blood samples week 6, 10, 16 and 20 after enrollment

Study Arms (2)

Coenzyme Q10

ACTIVE COMPARATOR

Drug: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Coenzyme Q10 DRUG

Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.

Also known as: Myoquinon

Coenzyme Q10

Placebo DRUG

A soft gelatin capsule containing soy oil, 5 capsules a day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• Pharma Nord: collaborator

Study Sites (1)

Department of Infectious Diseases

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36337437 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Line Khalidan Vibholm, M.D., Ph.D

  Department of Infections Diseases, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 13, 2021
• Study Start: May 25, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 6, 2022

Record last verified: 2021-06

Locations

DK (1)