Coenzyme Q10 as Treatment for Long Term COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-02-10

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Covid19 Long Term Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Coenzyme Q10

Group Type ACTIVE_COMPARATOR

Coenzyme Q10

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Coenzyme Q10

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Myoquinon

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No