COVID-19 Confirmed CasesNCT04463862
COVID - AirPollution
An observational study of COVID-19 Confirmed Cases and COVID-19 Mortality, run by University Hospital, Strasbourg, France at 8 sites in 2 countries.
Trial summary
Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be related to an increase in the COVID-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COVID-19 Confirmed Cases, COVID-19 Mortality
- How many people
- 660 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Jun 2020to 1 Jun 2021
- How long will I take part?
- 6 Months
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in geriatric departments between 2020/01/01 to 2020/06/01
Who may be able to join
- Patient over 60 years old (or dementia patient over 50 years old)
- Patient hospitalized in a geriatric department over the period from 2020/01/01 to 2020/06/01
- Patient who underwent RT-PCR SARS-CoV-2
- Patient (or trusted person/ legal guardian/curator, if applicable) who has given consent to the re-use of his/her data (patient data) for research purposes
Who cannot join
- None
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites
Unité de soins palliatifs gériatriques, Centre Hospitalier Départemental de Bischwiller
Bischwiller, 67241
Service de Gériatrie, Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, 85925
Service de médecine aigüe gériatrique, Hôpital Nord Laennec, Hôpitaux Universitaires de Nantes
Nantes, 44093
Service de Gériatrie, Hôpitaux Bichat et Bretonnaux, Assistance Publique des Hôpitaux de Paris
Paris, 75018
Service de Médecine Interne et Gériatrie, Hôpitaux Universitaires de Reims
Reims, 51100
Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Service de médecine gériatrique, Hôpitaux Universitaires de Tours
Tours, 37044
Belgium1 site
Unité de neurologie-gériatrie, Hôpital Erasme, Cliniques Universitaires de Bruxelles
Brussels, 1090
About this study
Official title: Air Pollution and COVID-19 Mortality in Geriatric Patients: a Multicenter Study
Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be related to an increase in the COVID-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory diseases and diabetes that are also the main comorbidities associated with COVID-19. Epidemiological studies using individual data are needed to provide more precise estimate of the association between air pollution exposure and COVID-19. In this multicenter prospective study, the investigators will analyze the number of deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI. Exposure to air pollution will be estimated as the mean concentration of air pollutants at the residential address during the previous two years. In addition, the investigators will explore the relationship between short-term variations in air pollutants, relative humidity, temperature, UV radiations, pollen and the occurrence of COVID-19.
- Conditions
- COVID-19 Confirmed Cases, COVID-19 Mortality
- Keywords
- Air pollution, COVID-19, Respiratory viral diseases, PM- NO2-Ozone
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 related-mortality
Association between COVID-19 related-mortality and air pollutants concentrations estimated at the residential address of geriatric patients during the last 2 years ( from 2018/01/01 to 2019/12/31)
Measured: COVID-19 mortality between 2020/01/01 and 2020/06/01
Secondary outcomes (1)
COVID-19 confirmed cases
Association between short- term variations in air pollutants, temperature, humidity, UV, pollens and the occurrence of COVID-19 confirmed cases.
Short-term variations are defined as changes in air pollutants concentrations, temperature, humidity and pollen during the 20 days preceding the hospitalization.
Measured: COVID-19 confirmed cases between 2020/01/01 and 2020/06/01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start4 Jun 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Confirmed CasesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 660 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric BLANC, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463862
- Sponsor's protocol ID
- 7922
- Status last verified
- Jun 2021
- First submitted
- 8 Jul 2020
- Last updated
- 25 Jun 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 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Pollution and COVID-19 Mortality in Geriatric Patients: a Multicenter Study
- ClinicalTrials.gov ID
- NCT04463862
- Acronym / sponsor ID
- 7922
- Conditions
- COVID-19 Confirmed Cases, COVID-19 Mortality
- Keywords
- Air pollution, COVID-19, Respiratory viral diseases, PM- NO2-Ozone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 9 Jul 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.
Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be related to an increase in the COVID-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory diseases and diabetes that are also the main comorbidities associated with COVID-19. Epidemiological studies using individual data are needed to provide more precise estimate of the association between air pollution exposure and COVID-19. In this multicenter prospective study, the investigators will analyze the number of deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI. Exposure to air pollution will be estimated as the mean concentration of air pollutants at the residential address during the previous two years. In addition, the investigators will explore the relationship between short-term variations in air pollutants, relative humidity, temperature, UV radiations, pollen and the occurrence of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in geriatric departments between 2020/01/01 to 2020/06/01
Key inclusion criteria (4 listed)
- Patient over 60 years old (or dementia patient over 50 years old)
- Patient hospitalized in a geriatric department over the period from 2020/01/01 to 2020/06/01
- Patient who underwent RT-PCR SARS-CoV-2
- Patient (or trusted person/ legal guardian/curator, if applicable) who has given consent to the re-use of his/her data (patient data) for research purposes
Key exclusion criteria (1 listed)
- None
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
COVID-19 related-mortality
Time frame: COVID-19 mortality between 2020/01/01 and 2020/06/01
Association between COVID-19 related-mortality and air pollutants concentrations estimated at the residential address of geriatric patients during the last 2 years ( from 2018/01/01 to 2019/12/31)
1 secondary outcome
COVID-19 confirmed cases
Time frame: COVID-19 confirmed cases between 2020/01/01 and 2020/06/01
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 25 Jun 2021.
- Individual participant dataSharing planned: No
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.
Frédéric BLANC, MD principal investigator
Hôpitaux Universitaires de Strasbourg
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Confirmed Cases and COVID-19 Mortality, run by University Hospital, Strasbourg, France at 8 sites in 2 countries.
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 4 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium. 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?
COVID-19 related-mortality (time frame: COVID-19 mortality between 2020/01/01 and 2020/06/01). 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 25 Jun 2021.