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

NCT05178225 | Completed

• 1 other identifier: COVID-19-SK001/2021
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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 post-COVID-19 syndrome.

Conditions

COVID-19 Respiratory Infection

Keywords

Mountain spa rehabilitation; post-COVID-19 syndrome; SARS-CoV-2; pulmonary function; clinical symptoms; platelet mitochondrial metabolism; coenzyme Q10; oxidative stress

Outcome Measures

Primary Outcomes (5)

• 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)

  3 weeks

• 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 (%)

  3 weeks

• 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

  3 weeks

• 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)

  3 weeks

• 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)

  3 weeks

Study Arms (3)

patients with post-COVID-19 syndrome with Mountain spa rehabilitation

ACTIVE COMPARATOR

patients 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

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 Q10

ACTIVE COMPARATOR

patients 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

Dietary Supplement: ubiquinol (reduced coenzyme Q10); Other: mountain spa rehabilitation; Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant

healthy control

PLACEBO COMPARATOR

15 healthy control volunteers (no Covid-19 or other pathologies)

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

Interventions

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.

patients with post-COVID-19 syndrome with Mountain spa rehabilitation + supplementation coenzyme Q10

mountain spa rehabilitation OTHER

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.

patients with post-COVID-19 syndrome with Mountain spa rehabilitation; patients with post-COVID-19 syndrome with Mountain spa rehabilitation + supplementation coenzyme Q10

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

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

healthy control; patients with post-COVID-19 syndrome with Mountain spa rehabilitation; patients with post-COVID-19 syndrome with Mountain spa rehabilitation + supplementation coenzyme Q10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• no COVID-19 patients

Sponsors & Collaborators

• Comenius University: lead
• Sanatórium of Dr. Guhr, n.o.: collaborator
• Kaneka Pharma Europe N.V.: collaborator

Study Sites (1)

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

Bratislava, 81108, Slovakia

Location

Related Publications (17)

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• 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.

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• Gvozdjakova A, Kucharska J, Rausova Z, Lopez-Lluch G, Navas P, Palacka P, Bartolcicova B, Sumbalova Z. Effect of Vaccination on Platelet Mitochondrial Bioenergy Function of Patients with Post-Acute COVID-19. Viruses. 2023 Apr 28;15(5):1085. doi: 10.3390/v15051085.

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• Sumbalova Z, Kucharska J, Rausova Z, Palacka P, Kovalcikova E, Takacsova T, Mojto V, Navas P, Lopez-Lluch G, Gvozdjakova A. Reduced platelet mitochondrial respiration and oxidative phosphorylation in patients with post COVID-19 syndrome are regenerated after spa rehabilitation and targeted ubiquinol therapy. Front Mol Biosci. 2022 Oct 21;9:1016352. doi: 10.3389/fmolb.2022.1016352. eCollection 2022.

  PMID: 36339707 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

ubiquinol; ubiquinol-10

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 5, 2022
• Study Start: May 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: January 1, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)