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Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse

NCT04356417 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6000000

Last updated 2020-04-22

No results posted yet for this study

Summary

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:

* Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS;
* Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists.

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

* Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors).
* Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities.

This in order to:

* To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD.
* To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

Conditions

  • AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection

Interventions

OTHER

- Synthetic anti-malarial drugs

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.

Sponsors & Collaborators

  • GIS EPI-PHARE

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Emilie SBIDIAN, Pr · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356417 on ClinicalTrials.gov