AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 InfectionTRAPSAHNCT04356417
Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse
An observational study of AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection
- What is being tested?
- - Synthetic anti-malarial drugs
- How many people
- 6,000,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2020to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Refer to eligibility criteria
Who may be able to join
- 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:
- 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)
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94000
Emilie Sbidian, Pr, +33 6 83 31 66 96, emilie.sbidian@aphp.fr
About this study
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.
Read more
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.
Read the 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)
- Being tested
- - Synthetic anti-malarial drugs
- Keywords
- Prevent COVID-19 infection, Synthetic antimalarial drugs (AMD), Anti-hypertensive drugs (ACEi's/ARB), SNSD, PMSI, Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Synthetic anti-malarial drugsOther
Also called - Converting enzyme inhibitors and angiotensin receptor antagonists
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 2020/01/01 to 2020/06/30
Secondary outcomes (4)
Pneumonia infections
Measured: From 2020/01/01 to 2020/06/30
ICU stay
Measured: From 2020/01/01 to 2020/06/30
Oro-tracheal intubation
Measured: From 2020/01/01 to 2020/06/30
Death
Measured: From 2020/01/01 to 2020/06/30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GIS EPI-PHARE
- Responsible party
- Sponsor
- Investigators
- Emilie SBIDIAN, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356417
- Sponsor's protocol ID
- APHP200412
- Acronym
- TRAPSAH
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04356417
- Acronym / sponsor ID
- TRAPSAH / APHP200412
- Keywords
- Prevent COVID-19 infection, Synthetic antimalarial drugs (AMD), Anti-hypertensive drugs (ACEi's/ARB), SNSD, PMSI, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GIS EPI-PHARE
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Refer to eligibility criteria
Key inclusion criteria (4 listed)
- 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:
- 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)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - Synthetic anti-malarial drugsAlso: - Converting enzyme inhibitors and angiotensin receptor antagonistsPrevalent 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 | – |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie SBIDIAN, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie SBIDIAN, Pr (+33 6 83 31 66 96, emilie.sbidian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of serious COVID-19 infections (time frame: From 2020/01/01 to 2020/06/30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.