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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04463862
Other study ID # 7922
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2020
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 660
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Unité de neurologie-gériatrie, Hôpital Erasme, Cliniques Universitaires de Bruxelles Bruxelles
France Unité de soins palliatifs gériatriques, Centre Hospitalier Départemental de Bischwiller Bischwiller
France Service de Gériatrie, Centre Hospitalier Départemental de Vendée La Roche Sur Yon
France Service de médecine aigüe gériatrique, Hôpital Nord Laennec, Hôpitaux Universitaires de Nantes Nantes
France Service de Gériatrie, Hôpitaux Bichat et Bretonnaux, Assistance Publique des Hôpitaux de Paris Paris
France Service de Médecine Interne et Gériatrie, Hôpitaux Universitaires de Reims Reims
France Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg Strasbourg
France Service de médecine gériatrique, Hôpitaux Universitaires de Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) COVID-19 mortality between 2020/01/01 and 2020/06/01
Secondary 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.
COVID-19 confirmed cases between 2020/01/01 and 2020/06/01