Covid19NCT04631861
Physical Activity and the Risk of COVID-19 Infection and Mortality
An observational study of Covid19, run by Wonju Severance Christian Hospital.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, there is no cure for COVID-19, except for supportive treatments. Quarantine for a defined period is the best option to reduce the spread of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 132,069 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Korean nationwide COVID-19 study was a retrospective, nationwide study including all Koreans who tested positive for SARS-CoV-2, aimed at evaluating the characteristics and outcomes of patients with COVID-19. Case patients were defined as individuals over 18 years old with positive results for the SARS-CoV-2 test. For every case patient, we selected up to 20 random controls from the target population who underwent the national health screening.
Who may be able to join
- all Koreans who tested positive for SARS-CoV-2
- more than 18 years old
- who underwent public health screening between 2014 and 2017
Who cannot join
- missing values about physical activity
About this study
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, there is no cure for COVID-19, except for supportive treatments. Quarantine for a defined period is the best option to reduce the spread of COVID-19. Physical activity has been shown to reduce the risk of serious community-acquired infections. However, it remains unanswered is whether physical activity has protective effects against SARS-CoV-2 infection and COVID-19 related mortality. This study aimed to examine the association of PA with the morbidity and mortality of COVID-19 infection in the entire South Korean population.
- Conditions
- Covid19
- Keywords
- Physical activity
- Medical subject headings
- COVID-19, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 positivity rate (%)
The SARS-CoV-2 infection was confirmed using the real-time reverse transcriptase polymerase chain reaction of pharyngeal and nasal swab samples, in accordance with the WHO recommendations
Measured: 7 years
COVID-19 related mortality rate (%)
The COVID-19 related mortality was defined as the termination of isolation due to death.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jan 2014
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 132,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Hyuk Cho, Wonju Severance Christian Hospital
- Investigators
- Dong-Hyuk Cho, Principal investigator, Yonsei Wonju Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631861
- Sponsor's protocol ID
- 2020AN0292
- Status last verified
- Jul 2023
- First submitted
- 14 Nov 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The present study are not publicly accessible due to Korean personal information projection act.
Publications
Phelan AL, Katz R, Gostin LO. The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance. JAMA. 2020 Feb 25;323(8):709-710. doi: 10.1001/jama.2020.1097. No abstract available.
PubMed 31999307Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020 Mar 19;91(1):157-160. doi: 10.23750/abm.v91i1.9397.
PubMed 32191675Kim DW, Byeon KH, Kim J, Cho KD, Lee N. The Correlation of Comorbidities on the Mortality in Patients with COVID-19: an Observational Study Based on the Korean National Health Insurance Big Data. J Korean Med Sci. 2020 Jul 6;35(26):e243. doi: 10.3346/jkms.2020.35.e243.
PubMed 32627443Hamer M, Kivimaki M, Gale CR, Batty GD. Lifestyle risk factors, inflammatory mechanisms, and COVID-19 hospitalization: A community-based cohort study of 387,109 adults in UK. Brain Behav Immun. 2020 Jul;87:184-187. doi: 10.1016/j.bbi.2020.05.059. Epub 2020 May 23.
PubMed 32454138
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and the Risk of COVID-19 Infection and Mortality
- ClinicalTrials.gov ID
- NCT04631861
- Acronym / sponsor ID
- 2020AN0292
- Conditions
- Covid19
- Keywords
- Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132,069 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 17 Nov 2020 (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.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, there is no cure for COVID-19, except for supportive treatments. Quarantine for a defined period is the best option to reduce the spread of COVID-19. Physical activity has been shown to reduce the risk of serious community-acquired infections. However, it remains unanswered is whether physical activity has protective effects against SARS-CoV-2 infection and COVID-19 related mortality. This study aimed to examine the association of PA with the morbidity and mortality of COVID-19 infection in the entire South Korean population.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Korean nationwide COVID-19 study was a retrospective, nationwide study including all Koreans who tested positive for SARS-CoV-2, aimed at evaluating the characteristics and outcomes of patients with COVID-19. Case patients were defined as individuals over 18 years old with positive results for the SARS-CoV-2 test. For every case patient, we selected up to 20 random controls from the target population who underwent the national health screening.
Key inclusion criteria (3 listed)
- all Koreans who tested positive for SARS-CoV-2
- more than 18 years old
- who underwent public health screening between 2014 and 2017
Key exclusion criteria (1 listed)
- missing values about physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SARS-CoV-2 positivity rate (%)
Time frame: 7 years
The SARS-CoV-2 infection was confirmed using the real-time reverse transcriptase polymerase chain reaction of pharyngeal and nasal swab samples, in accordance with the WHO recommendations
COVID-19 related mortality rate (%)
Time frame: 7 years
The COVID-19 related mortality was defined as the termination of isolation due to death.
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 1 Aug 2023.
- Results publication: PubMed 31999307Phelan AL, Katz R, Gostin LO. The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance. JAMA. 2020 Feb 25;323(8):709-710. doi: 10.1001/jama.2020.1097. No abstract available.
- Results publication: PubMed 32191675Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020 Mar 19;91(1):157-160. doi: 10.23750/abm.v91i1.9397.
- Results publication: PubMed 32627443Kim DW, Byeon KH, Kim J, Cho KD, Lee N. The Correlation of Comorbidities on the Mortality in Patients with COVID-19: an Observational Study Based on the Korean National Health Insurance Big Data. J Korean Med Sci. 2020 Jul 6;35(26):e243. doi: 10.3346/jkms.2020.35.e243.
- Results publication: PubMed 32454138Hamer M, Kivimaki M, Gale CR, Batty GD. Lifestyle risk factors, inflammatory mechanisms, and COVID-19 hospitalization: A community-based cohort study of 387,109 adults in UK. Brain Behav Immun. 2020 Jul;87:184-187. doi: 10.1016/j.bbi.2020.05.059. Epub 2020 May 23.
- Individual participant dataSharing planned: No. The present study are not publicly accessible due to Korean personal information projection act.
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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.
Dong-Hyuk Cho principal investigator
Yonsei Wonju Christian Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Wonju Severance Christian Hospital.
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 3 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
SARS-CoV-2 positivity rate (%) (time frame: 7 years). The study lists 2 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 NCT04631861, which also lists 4 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 1 Aug 2023.