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Coenzyme Q10 as Treatment for Long Term COVID-19 (QVID)

A

Aarhus University Hospital

Status and phase

Completed
Phase 2

Conditions

Long Term Covid19
Covid19

Treatments

Drug: Placebo
Drug: Coenzyme Q10

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04960215
QVID-001

Details and patient eligibility

About

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).

Full description

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

121 participants in 2 patient groups, including a placebo group

Coenzyme Q10
Active Comparator group
Treatment:
Drug: Coenzyme Q10
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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