Coenzyme Q10 as Treatment for Long Term COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Coenzyme Q10
干预措施: Coenzyme Q10 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Coenzyme Q10 treatment in Long Term COVID-19 on number of self-reported symptoms of LTC measured by EQ-5D-5L questionnaire.
时间窗: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Number of self-reported symptoms measured by EQ-5D-5L questionnaire.
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.
时间窗: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
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.
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.
时间窗: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
Number of self-reported symptoms measured by Long Term COVID-specific questionnaire.
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.
时间窗: Changes from baseline questionnaire response to questionnaire response after 6 weeks of treatment
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.
次要结局
- 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 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 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.)