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

January 4, 2022 updated by: Comenius University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 81108
        • Pharmacobiochemical Laboratory of Third Department of Internal Medicine, Faculty of Medicine Comenius University in Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no COVID-19 patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients with post-COVID-19 syndrome with Mountain spa rehabilitation
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
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.
Diagnostic test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
2x14 ml of peripheral blood collected in a tube with anticoagulant
Active Comparator: patients with post-COVID-19 syndrome with Mountain spa rehabilitation + supplementation coenzyme Q10
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
Other: mountain spa rehabilitation
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.
Diagnostic test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
2x14 ml of peripheral blood collected in a tube with anticoagulant
Dietary supplement: ubiquinol (reduced coenzyme Q10)
supplementation with ubiquinol (reduced coenzyme Q10), in a daily dose of 2x100 mg. one morning after breakfast, and second dose after dinner.
Placebo Comparator: healthy control
15 healthy control volunteers (no Covid-19 or other pathologies)
Diagnostic test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
2x14 ml of peripheral blood collected in a tube with anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood count and metabolites
Time Frame: 3 weeks

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
Time Frame: 3 weeks
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)
Time Frame: 3 weeks
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
Time Frame: 3 weeks
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
Time Frame: 3 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comenius University

Collaborators

Sanatórium of Dr. Guhr, n.o.
Kaneka Pharma Europe N.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19-SK001/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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