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

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ClinicalTrials.gov Identifier: NCT04356417
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
GIS EPI-PHARE
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection Other: - Synthetic anti-malarial drugs

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)

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Study Type : Observational
Estimated Enrollment : 6000000 participants
Observational Model: Cohort
Time Perspective: Other
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Intervention Details:
  • 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.
    Other Name: - Converting enzyme inhibitors and angiotensin receptor antagonists


Primary Outcome Measures :
  1. Identification of serious COVID-19 infections [ Time Frame: From 2020/01/01 to 2020/06/30 ]
    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.


Secondary Outcome Measures :
  1. Pneumonia infections [ Time Frame: From 2020/01/01 to 2020/06/30 ]
  2. ICU stay [ Time Frame: From 2020/01/01 to 2020/06/30 ]
  3. Oro-tracheal intubation [ Time Frame: From 2020/01/01 to 2020/06/30 ]
  4. Death [ Time Frame: From 2020/01/01 to 2020/06/30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Refer to eligibility criteria
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

No Exclusion Criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356417


Contacts
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Contact: Emilie SBIDIAN, Pr +33 6 83 31 66 96 emilie.sbidian@aphp.fr

Locations
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France
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, France, 94000
Contact: Emilie Sbidian, Pr    +33 6 83 31 66 96    emilie.sbidian@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GIS EPI-PHARE
Investigators
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Principal Investigator: Emilie SBIDIAN, Pr Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04356417    
Other Study ID Numbers: APHP200412
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prevent COVID-19 infection
Synthetic antimalarial drugs (AMD)
Anti-hypertensive drugs (ACEi's/ARB)
SNSD
PMSI
Cohort
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Antimalarials
Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents