An observational study in AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold.
Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19.
Treatments currently being investigated include:
We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease.
Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are
This in order to:
Details for "Study design" section
Time perspective : Retrospective and prospective cohort study using French National Health Database Data source
Enrollment:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 6,000,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Refer to eligibility criteria
Inclusion Criteria:
All adults (18 years of age and older) registered in the French national health insurance database (SNDS) receiving between January 1, 2020, and May 31, 2020:
No Exclusion Criteria
Prevalent users will be those with at least one dispensing of AMD or ARBs/ACEi's from 01/01/2019 to 01/01/2020. Exposed users will be those among prevalent users who still received AMD or ARBs/ACEi's on 31/12/2019. The inclusion period will be from 01/01/2019 to 01/01/2020. The study end date will be 30/06/2020. For each treatment AMD or ARB/ACRi's, the persistence of treatment will be defined as the length of time from initiation to discontinuation. Initiation will be the date of the first reimbursement of AMD or ARB/ACRi's during the inclusion period. We will define the discontinuation of treatment as a period of more than 90 days without fulfilment of a prescription for the same treatment after the period covered by the previous prescription i.e 30 days. Exposure to a combination of drugs will be defined as a period shorter than 30 days between the prescription of two different systemic drugs and the fulfilment of another prescription for both drugs in the following 90 days.
Also known as: - Converting enzyme inhibitors and angiotensin receptor antagonists
Identification of serious COVID-19 infections
Participants as those with the emergency ICD-10 (international classification of diseases, 10th revision) code of U07.1 which was assigned to the disease diagnosis of COVID-19.
Time frame: From 2020/01/01 to 2020/06/30
Pneumonia infections
Time frame: From 2020/01/01 to 2020/06/30
ICU stay
Time frame: From 2020/01/01 to 2020/06/30
Oro-tracheal intubation
Time frame: From 2020/01/01 to 2020/06/30
Death
Time frame: From 2020/01/01 to 2020/06/30
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris