AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection Clinical Trial
Official title:
Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse: Cases of Synthetic Antimalarial Drugs and Anti-hypertensive Drugs
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.
Details for "Study design" section
Time perspective : Retrospective and prospective cohort study using French National Health
Database Data source
Enrollment:
- 70,000 patients treated by synthetic AMD
- 13 million patients treated by ARBs or ACEi's from the French national health insurance
database (SNDS) and the French national hospital discharge database (Programme de
Médicalisation des Systèmes d'Information, PMSI)
;