Spa Rehabilitation, Antioxidant and Bioenergetic Supportive Treatment of Patients With Post-Covid-19 Syndrome (SpaCOVID)
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| ClinicalTrials.gov Identifier: NCT05178225 |
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Recruitment Status :
Completed
First Posted : January 5, 2022
Last Update Posted : January 20, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 Respiratory Infection | Dietary Supplement: ubiquinol (reduced coenzyme Q10) Other: mountain spa rehabilitation Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Spa Rehabilitation, Antioxidant and Bioenergetic Supportive Treatment of Patients With Post-Covid-19 Syndrome |
| Actual Study Start Date : | May 1, 2021 |
| Actual Primary Completion Date : | June 30, 2021 |
| Actual Study Completion Date : | January 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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
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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. 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 |
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Placebo Comparator: healthy control
15 healthy control volunteers (no Covid-19 or other pathologies)
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Diagnostic Test: 2x14 ml of peripheral blood collected in a tube with anticoagulant
2x14 ml of peripheral blood collected in a tube with anticoagulant |
- 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)
- 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 (%)
- 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
- 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)
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- patients with post-COVID-19 syndrome, 3-6 months after hospitalization
Exclusion Criteria:
- no COVID-19 patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178225
| Slovakia | |
| Pharmacobiochemical Laboratory of Third Department of Internal Medicine, Faculty of Medicine Comenius University in Bratislava | |
| Bratislava, Slovakia, 81108 | |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Comenius University |
| ClinicalTrials.gov Identifier: | NCT05178225 |
| Other Study ID Numbers: |
COVID-19-SK001/2021 |
| First Posted: | January 5, 2022 Key Record Dates |
| Last Update Posted: | January 20, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Mountain spa rehabilitation post-COVID-19 syndrome SARS-CoV-2 pulmonary function |
clinical symptoms platelet mitochondrial metabolism coenzyme Q10 oxidative stress |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ubiquinone Coenzyme Q10 Anticoagulants Micronutrients Physiological Effects of Drugs Vitamins |