AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection Clinical Trial
— TRAPSAHOfficial 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
| NCT number | NCT04356417 |
| Other study ID # | APHP200412 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2020 |
| Est. completion date | June 2020 |
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.
| Status | Not yet recruiting |
| Enrollment | 6000000 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Paris - CHU Henri Mondor | Créteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | GIS EPI-PHARE |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From 2020/01/01 to 2020/06/30 | |
| Secondary | Pneumonia infections | From 2020/01/01 to 2020/06/30 | ||
| Secondary | ICU stay | From 2020/01/01 to 2020/06/30 | ||
| Secondary | Oro-tracheal intubation | From 2020/01/01 to 2020/06/30 | ||
| Secondary | Death | From 2020/01/01 to 2020/06/30 |