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

NCT ID: NCT04356417

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 6000000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-06-30

Brief 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.

Detailed Description

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)

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

- 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.

Intervention Type: OTHER

Other Intervention Names

- Converting enzyme inhibitors and angiotensin receptor antagonists

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:

1. Synthetic anti-malarial drugs (AMD): Participants will be identified by the prescription of at least one synthetic AMD (chloroquine and hydroxychloroquine, ATC P01D1 and M01C respectively)

2. Anti-hypertensive drugs: Participants will be identified by the prescription of at least one Angiotensin receptor-blocking or Angiotensin converting- enzyme inhibitors, ATC C09A-D

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GIS EPI-PHARE

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie SBIDIAN, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, , France

Countries

France

Central Contacts

Emilie SBIDIAN, Pr

Role: CONTACT

emilie.sbidian@aphp.fr

+33 6 83 31 66 96

Facility Contacts

Emilie Sbidian, Pr

Role: primary

emilie.sbidian@aphp.fr

+33 6 83 31 66 96

Other Identifiers

APHP200412

Identifier Type: -

Identifier Source: org_study_id