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COVID-19 Respiratory InfectionSpaCOVIDNCT05178225

Spa Rehabilitation, Antioxidant and Bioenergetic Supportive Treatment of Patients With Post-Covid-19 Syndrome

A study testing ubiquinol (reduced coenzyme Q10), mountain spa rehabilitation and 2x14 ml of peripheral blood collected in a tube with anticoagulant in people with COVID-19 Respiratory Infection, run by Comenius University at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our hypothesis - that 21 days of mountain spa rehabilitation with ubiquinol supplementation could to accelerate regeneration of patients with post-COVID-19 syndrome, based on the improving platelet mitochondrial bioenergetic, decreasing of oxidative stress and improving of antioxidants protections of patients with… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
ubiquinol (reduced coenzyme Q10), mountain spa rehabilitation and 2x14 ml of peripheral blood collected in a tube with anticoagulant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteSlovakia
Study dates
1 May 2021to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients with post-COVID-19 syndrome, 3-6 months after hospitalization

Who cannot join

  • no COVID-19 patients

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • Pharmacobiochemical Laboratory of Third Department of Internal Medicine, Faculty of Medicine Comenius University in Bratislava

    Bratislava, 81108

Other trials in Slovakia

About this study

Our hypothesis - that 21 days of mountain spa rehabilitation with ubiquinol supplementation could to accelerate regeneration of patients with post-COVID-19 syndrome, based on the improving platelet mitochondrial bioenergetic, decreasing of oxidative stress and improving of antioxidants protections of patients with post-COVID-19 syndrome.

Read the detailed description

The first new coronavirus originated from southeast China in 2003 (SARS - Severe Acute Respiratory Syndrome), and the second was originated from Middle East in 2012 (MERS - Middle East Respiratory Syndrome). In March 2020, the World Health Organization declared a global pandemic caused by the SARS-CoV-2 beta-coronavirus responsible for a new type of acute respiratory infection and atypical pneumonia. Persisting signs or symptoms over 12 weeks after the SARS-CoV-2 infection, are defined as post-COVID-19 syndrome. The main symptoms include shortness of breath, general fatigue, exhaustion, headaches, muscle and joint pain, cough, hair, taste and smell loss, sleep and memory disturbances, depression, sensitivity to sound and light.

SARS-CoV-2 viral infection occurs with higher incidence in patients with comorbidities such as diabetes mellitus Type 2, obesity, cardiovascular disease, chronic lung disease and cancer. In aged individuals immune system and mitochondrial dysfunction are a key factors in COVID-19 disease. Mechanical oxygen saturation is required primarily in patients with comorbidities and post-hospitalization pulmonary rehabilitation may be considered in all patients with COVID-19.

Many viruses modulate mitochondrial function, producing more reactive oxygen species, (ROS), cytokine storm, and stimulate inflammation. The investigators published the hypothesis that a target of the new SARS-CoV-2 virus could be mitochondrial bioenergetics and endogenous coenzyme Q10 level. Currently our question was partially answered by authors, who showed reduced mitochondrial bioenergetics in monocytes and peripheral blood mononuclear cells of patients with COVID-19, and the investigators found reduced platelet mitochondrial function in non-hospitalized patients after acute COVID-19 . In the last years isolated platelets from circulating blood are used for estimation of mitochondrial bioenergetics in various diseases, as in patients with chronic kidney diseases, in patients after kidney transplantation, in patients with rheumatoid arthritis. However, the effect of SARS-CoV-2 on platelet mitochondrial function in patients non-vaccinated, hospitalized after infection of SARS-CoV-2 (with post-COVID-19 syndrome), as well as effect of mountain spa rehabilitation on platelet mitochondrial function of patients with post-COVID-19 syndrome has not been published.

Mountain spa rehabilitation (MR) is beneficial for chronic pulmonary diseases, improving fatique, joint pain, psychological stress, sleep disorders and quality of life in patients with various diseases. The investigators assume that special spa rehabilitation in the mountain High Tatras may regenerate impaired mitochondrial metabolism of patients with post-COVID-19 syndrome, can improve physical and mental activity, immunity, reduce oxidative stress and contribute to the acceleration of recovery of patients with post-COVID-19 syndrome.

Being tested
ubiquinol (reduced coenzyme Q10), mountain spa rehabilitation, 2x14 ml of peripheral blood collected in a tube with anticoagulant
Keywords
Mountain spa rehabilitation, post-COVID-19 syndrome, SARS-CoV-2, pulmonary function, clinical symptoms, platelet mitochondrial metabolism, coenzyme Q10, oxidative stress
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ubiquinol (reduced coenzyme Q10)Dietary supplement

    supplementation with ubiquinol (reduced coenzyme Q10), in a daily dose of 2x100 mg. one morning after breakfast, and second dose after dinner.

  • mountain spa rehabilitationOther

    special spa rehabilitation in the mountain High Tatras; Functional capacity of the lungs (6MWT) at before and after 16-18 days of rehabilitation, Borg scale for dyspnea and oxygen saturation SpO2 (%) were monitored.

  • 2x14 ml of peripheral blood collected in a tube with anticoagulantDiagnostic test

    2x14 ml of peripheral blood collected in a tube with anticoagulant

Study groups in NCT05178225
Study groupRoleWhat they receive
patients with post-COVID-19 syndrome with Mountain spa rehabilitationActive comparatorpatients with post-COVID-19 syndrome with Mountain spa rehabilitation: 15 patients with post-COVID-19 syndrome, 3-6 months after hospitalization were on Mountain spa rehabilitation (MR) in High Tatras, Tatranská Polianka, Slovakia, for 16 to 18 days
Receives: Other: mountain spa rehabilitation; Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
patients with post-COVID-19 syndrome with Mountain spa rehabilitation + supplementation coenzyme Q10Active comparatorpatients with post-COVID-19 syndrome with Mountain spa rehabilitation: 22 patients with post-COVID-19 syndrome, 3-6 months after hospitalization were on Mountain spa rehabilitation (MR) in High Tatras, Tatranská Polianka, Slovakia, 22 patients who will be on spa rehabilitation and at the same time on supplementation with ubiquinol (reduced coenzyme Q10), in a daily dose of 2x100 mg, for 16 to 18 days
Receives: Dietary Supplement: ubiquinol (reduced coenzyme Q10); Other: mountain spa rehabilitation; Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
healthy controlPlacebo comparator15 healthy control volunteers (no Covid-19 or other pathologies)
Receives: Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood count and metabolites

    2x14 ml of peripheral blood collected in a tube with anticoagulant- two collections before and after Mountain spa rehabilitation Blood count WBC (10to9/L) RBC (10to9/L) HCT (ratio) PLT (10to9/L) MCV (fL) MCH (pg) MCHC (g/L) HgB (g/L)

    Lipids parameters CHOL (mmol/L) HDL-CH (mmol/L) LDL-CH (mmol/L) TAG (mmol/L)

    CRP (mg/L)

    Measured: 3 weeks

  2. lungs function

    Effect of MR on lungs function Functional capacity of the lungs- walking distance during the 6MWT (m) Exercise dyspnea measured by Borg scale BS (number) Oxygen saturation SpO2 (%)

    Measured: 3 weeks

  3. clinical symptoms (before and after MR)

    Dry cough Breathing Breathing difficulty Shortness of breath in rest Elevated temperature Chills Heart palpitations Respiratory support with Q2 Weakness Overall fatigue Malaise GIT problems Diarrhea Chest pain Muscle and joint pain Back pain Headache Loss of taste and smell Weight loss Hearing impairment Visual disturbance

    Measured: 3 weeks

  4. damaged platelet mitochondrial bioenergetics

    Basal oxygen consumption rate in intact platelets (ce) rate of mitochondrial LEAK respiration with CI-linked substrates (1PM - state 4) CI-linked respiration coupled with ATP production (2D- CI-linked oxidative phosphorylation capacity) respiration after addition of cytochrome c (2c) Maximal mitochondrial oxidative capacity (the electron transfer capacity, ET) after uncoupler titration (3U) After addition of exogenous substrate glutamate (4G) non-coupled mitochondrial oxygen consumption Non-coupled oxygen consumption with CI\&II-linked substrates (5S) mean of improvement of mitochondrial parameters representing OXPHOS- and electron transport capacity (ET-capacity)

    Measured: 3 weeks

  5. Endogenous coenzyme Q10 and TBARS

    Endogenous concentration of CoQ10-TOTAL (ubiquinone + ubiquinol) in platelets

    CoQ10-TOTAL in:

    Platelets (pmol.10-9 cells) Blood (µmol.L-1) Plasma (µmol.L-1) TBARS in plasma (µmol.L-1)

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start1 May 2021
  3. Primary completion30 Jun 2021
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178225
Sponsor's protocol ID
COVID-19-SK001/2021
Acronym
SpaCOVID
Status last verified
Jan 2022
First submitted
3 Jan 2022
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kucharska J, Gvozdjakova A, Mizera S, Braunova Z, Schreinerova Z, Schramekova E, Pechan I, Fabian J. Participation of coenzyme Q10 in the rejection development of the transplanted heart: a clinical study. Physiol Res. 1998;47(6):399-404.

    PubMed 10453746

  • Hilgenfeld R, Peiris M. From SARS to MERS: 10 years of research on highly pathogenic human coronaviruses. Antiviral Res. 2013 Oct;100(1):286-95. doi: 10.1016/j.antiviral.2013.08.015. Epub 2013 Sep 6.

    PubMed 24012996

  • Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.

    PubMed 32052466

  • Shi TT, Yang FY, Liu C, Cao X, Lu J, Zhang XL, Yuan MX, Chen C, Yang JK. Angiotensin-converting enzyme 2 regulates mitochondrial function in pancreatic beta-cells. Biochem Biophys Res Commun. 2018 Jan 1;495(1):860-866. doi: 10.1016/j.bbrc.2017.11.055. Epub 2017 Nov 9.

    PubMed 29128354

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264

  • Li JY, You Z, Wang Q, Zhou ZJ, Qiu Y, Luo R, Ge XY. The epidemic of 2019-novel-coronavirus (2019-nCoV) pneumonia and insights for emerging infectious diseases in the future. Microbes Infect. 2020 Mar;22(2):80-85. doi: 10.1016/j.micinf.2020.02.002. Epub 2020 Feb 20.

    PubMed 32087334

  • Lopez-Lluch G. Mitochondrial activity and dynamics changes regarding metabolism in ageing and obesity. Mech Ageing Dev. 2017 Mar;162:108-121. doi: 10.1016/j.mad.2016.12.005. Epub 2016 Dec 16.

    PubMed 27993601

  • Moreno Fernandez-Ayala DJ, Navas P, Lopez-Lluch G. Age-related mitochondrial dysfunction as a key factor in COVID-19 disease. Exp Gerontol. 2020 Dec;142:111147. doi: 10.1016/j.exger.2020.111147. Epub 2020 Nov 7.

    PubMed 33171276

  • Ganji R, Reddy PH. Impact of COVID-19 on Mitochondrial-Based Immunity in Aging and Age-Related Diseases. Front Aging Neurosci. 2021 Jan 12;12:614650. doi: 10.3389/fnagi.2020.614650. eCollection 2020.

    PubMed 33510633

  • Siddiq MAB, Rathore FA, Clegg D, Rasker JJ. Pulmonary Rehabilitation in COVID-19 patients: A scoping review of current practice and its application during the pandemic. Turk J Phys Med Rehabil. 2020 Nov 9;66(4):480-494. doi: 10.5606/tftrd.2020.6889. eCollection 2020 Dec.

    PubMed 33364571

  • Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.

    PubMed 32541352

  • Maccarone MC, Masiero S. Spa therapy interventions for post respiratory rehabilitation in COVID-19 subjects: does the review of recent evidence suggest a role? Environ Sci Pollut Res Int. 2021 Sep;28(33):46063-46066. doi: 10.1007/s11356-021-15443-8. Epub 2021 Jul 17.

    PubMed 34273080

  • Gvozdjakova A, Klauco F, Kucharska J, Sumbalova Z. Is mitochondrial bioenergetics and coenzyme Q10 the target of a virus causing COVID-19? Bratisl Lek Listy. 2020;121(11):775-778. doi: 10.4149/BLL_2020_126.

    PubMed 33164536

  • Gvozdjakova A, Sumbalova Z, Kucharska J, Chladekova A, Rausova Z, Vancova O, Komlosi M, Ulicna O, Mojto V. Platelet mitochondrial bioenergetic analysis in patients with nephropathies and non-communicable diseases: a new method. Bratisl Lek Listy. 2019;120(9):630-635. doi: 10.4149/BLL_2019_104.

    PubMed 31475544

  • Gvozdjakova A, Sumbalova Z, Kucharska J, Szamosova M, Capova L, Rausova Z, Vancova O, Mojto V, Langsjoen P, Palacka P. Platelet mitochondrial respiration and coenzyme Q10 could be used as new diagnostic strategy for mitochondrial dysfunction in rheumatoid diseases. PLoS One. 2021 Sep 28;16(9):e0256135. doi: 10.1371/journal.pone.0256135. eCollection 2021.

    PubMed 34582480

Questions about this trial

What is this clinical trial studying?

A study testing ubiquinol (reduced coenzyme Q10), mountain spa rehabilitation and 2x14 ml of peripheral blood collected in a tube with anticoagulant in people with COVID-19 Respiratory Infection, run by Comenius University at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood count and metabolites (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178225, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.

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