Covid19ICENCT04817280
COVID-19 in Polish Ice Swimmers.
An observational study of Covid19 and SARS-CoV Infection, run by Wroclaw Medical University at 3 sites in Poland.
Trial summary
Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection, Resistance, Disease
- What is being tested?
- Ice Swimming
- How many people
- 2,534 participants
- Where
- 3 sitesPoland
- Study dates
- 1 Dec 2020to 1 Mar 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Surveys are distributed en masse among ice swimmers from Poland. Comparative data for the control group is derived from officially published national and regional pandemic data.
Who may be able to join
- ice swimmers
Who cannot join
- not active ice swimmers
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Department of Radiotherapy of Multidisciplinary Provincial Hospital
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Department of Public Health at Wroclaw Medical University
Wroclaw, Dolny Slask, 51-618
Treasury Medical Company
Zielona Góra, Lubusz Voivodeship, 65-031
About this study
Official title: Influence of Ice Swimming on Hardening Against SARS-CoV-2 and Influence of AB0 Rh Blood Type on Viral Resistance in Polish Ice Swimmers.
Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.
Read the detailed description
The research tool is an original questionnaire compiled by a team of experts conducting the study. The survey includes questions about sociodemographic data, such as age and gender and blood type in AB0 system with Rh factor, and questions about the frequency of ice swimming, the duration of a single session, and since when respondents have been ice swimming. There was also a question about the respondents' compliance with the restrictions and recommendations related to the pandemic and contacts with people with confirmed SARS-CoV-2 infection. In the survey, researchers ask about the infectious symptoms experienced during the pandemic and about being diagnosed with COVID-19 or its exclusion. People who have been ill are asked about the place of treatment.
The questionnaires are collected in traditional form, on the Internet and as scans of documents. Each survey was completely anonymous. The obtained statistical data will be compared with official data on new COVID-19 cases and recoveries at the same time. Official data are published by the Ministry of Health and earlier also by Sanitary and Epidemiological Stations. The main aim of the study was to determine whether ice swimming also increases resistance to SARS-CoV-2 and COVID-19.
- Conditions
- Covid19, SARS-CoV Infection, Resistance, Disease, Hypothermia, Hypothermia Due to Cold Environment
- Being tested
- Ice Swimming
- Keywords
- Ice Swim, Immune System, Immunity, Temporarily cooling down
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Disease Resistance, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice SwimmingOther
The intervention is not made in the course of a research study. Ice swimming has been introduced earlier by a given group. The group was made up of people who already swim in ice.
| Study group | Role | What they receive |
|---|---|---|
| Ice Swimmers Group. | No intervention. Data obtained from Polish ice swimmers reported by them retrospectively in the questionnaire. Receives: Other: Ice Swimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of COVID-19 among ice swimmers compared to the general population.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Measured: 47 days.
Assessment of the frequency of asymptomatic SARS-CoV-2 infection among ice swimmers compared to the general population.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Measured: 47 days.
Assessment of the frequency of occurrence of particular symptoms of SARS-CoV-2 infection among ice swimmers compared to the general population.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Measured: 47 days.
Assessment of the frequency of COVID-19 treatment in an outpatient, inpatient and intensive care unit among ice swimmers compared to the general population.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Measured: 47 days.
Assessment of the impact of parameters and ice swimming strategies on the likelihood of developing COVID-19, the occurrence of individual symptoms of the disease and the severity of its course.
Inference from data obtained from surveys collected among ice swimmers.
Measured: 47 days.
Assessment of the influence of blood group on susceptibility to SARS-CoV-2 infection among ice swimmers.
Inference from data obtained from surveys collected among ice swimmers.
Measured: 47 days.
Secondary outcomes (1)
Assessment of the immunity of the ice swimmer's immune system compared to the general population.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Measured: 47 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Dec 2020
- Primary completion17 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylwia Sulimiera Michalak, MD, PhD, Study director, Department of Pharmacology and Toxicology, Medical University of Zielona GoraEdyta Wolny-Rokicka, MD, PhD, Study director, Department and Center of Radiotherapy, Multidisciplinary Provincial Hospital in Gorzow WielkopolskiAndrzej Tukiendorf, Prof., Study chair, Department of Public Health, Wroclaw Medical UniversityLukasz K Wysoczanski, MD, Principal investigator, Department of Family Medicine, Wroclaw Medical UniversityPaulina N Wysoczanska, MD, Principal investigator, Department of Family Medicine, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817280
- Sponsor's protocol ID
- KB-03/139/2021
- Acronym
- ICE
- Status last verified
- Apr 2021
- First submitted
- 24 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ice Swimming on Hardening Against SARS-CoV-2 and Influence of AB0 Rh Blood Type on Viral Resistance in Polish Ice Swimmers.
- ClinicalTrials.gov ID
- NCT04817280
- Acronym / sponsor ID
- ICE / KB-03/139/2021
- Conditions
- Covid19, SARS-CoV Infection, Resistance, Disease, Hypothermia, Hypothermia Due to Cold Environment
- Keywords
- Ice Swim, Immune System, Immunity, Temporarily cooling down
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,534 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.
Detailed description
The research tool is an original questionnaire compiled by a team of experts conducting the study. The survey includes questions about sociodemographic data, such as age and gender and blood type in AB0 system with Rh factor, and questions about the frequency of ice swimming, the duration of a single session, and since when respondents have been ice swimming. There was also a question about the respondents' compliance with the restrictions and recommendations related to the pandemic and contacts with people with confirmed SARS-CoV-2 infection. In the survey, researchers ask about the infectious symptoms experienced during the pandemic and about being diagnosed with COVID-19 or its exclusion. People who have been ill are asked about the place of treatment.
The questionnaires are collected in traditional form, on the Internet and as scans of documents. Each survey was completely anonymous. The obtained statistical data will be compared with official data on new COVID-19 cases and recoveries at the same time. Official data are published by the Ministry of Health and earlier also by Sanitary and Epidemiological Stations. The main aim of the study was to determine whether ice swimming also increases resistance to SARS-CoV-2 and COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ice Swimmers Group. | – | Other: Ice SwimmingNo intervention. Data obtained from Polish ice swimmers reported by them retrospectively in the questionnaire. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surveys are distributed en masse among ice swimmers from Poland. Comparative data for the control group is derived from officially published national and regional pandemic data.
Key inclusion criteria (1 listed)
- ice swimmers
Key exclusion criteria (1 listed)
- not active ice swimmers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice SwimmingThe intervention is not made in the course of a research study. Ice swimming has been introduced earlier by a given group. The group was made up of people who already swim in ice. | Other | Ice Swimmers Group. |
Primary outcome
Assessment of the incidence of COVID-19 among ice swimmers compared to the general population.
Time frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Assessment of the frequency of asymptomatic SARS-CoV-2 infection among ice swimmers compared to the general population.
Time frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Assessment of the frequency of occurrence of particular symptoms of SARS-CoV-2 infection among ice swimmers compared to the general population.
Time frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Assessment of the frequency of COVID-19 treatment in an outpatient, inpatient and intensive care unit among ice swimmers compared to the general population.
Time frame: 47 days.
Comparison of the data obtained from surveys collected among ice swimmers with the data published in official channels for the general population during this period.
Assessment of the impact of parameters and ice swimming strategies on the likelihood of developing COVID-19, the occurrence of individual symptoms of the disease and the severity of its course.
Time frame: 47 days.
Inference from data obtained from surveys collected among ice swimmers.
Assessment of the influence of blood group on susceptibility to SARS-CoV-2 infection among ice swimmers.
Time frame: 47 days.
Inference from data obtained from surveys collected among ice swimmers.
1 secondary outcome
Assessment of the immunity of the ice swimmer's immune system compared to the general population.
Time frame: 47 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylwia Sulimiera Michalak, MD, PhD study director
Department of Pharmacology and Toxicology, Medical University of Zielona Gora
Edyta Wolny-Rokicka, MD, PhD study director
Department and Center of Radiotherapy, Multidisciplinary Provincial Hospital in Gorzow Wielkopolski
Andrzej Tukiendorf, Prof. study chair
Department of Public Health, Wroclaw Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Wroclaw Medical University at 3 sites in Poland.
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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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. 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?
Assessment of the incidence of COVID-19 among ice swimmers compared to the general population. (time frame: 47 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2021.