Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05445479 |
| Other study ID # |
AP_BD_001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Nantes University Hospital |
| Contact |
Brigitte Dréno |
| Phone |
0240083118 |
| Email |
brigitte.dreno[@]atlanmed.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A new coronavirus, the third documented animal-to-human passage, emerged in Wuhan , China in
the last quarter of 2019. Acne patients on doxycycline escaped seasonal viruses, showing the
interest of this antibiotic as a possible treatment against COVID-19.
The antiviral action of tetracyclines can be explained by different mechanisms. First of all,
tetracyclines are modulators of innate immunity by decreasing NF-B expression, inhibiting
inflammatory cytokines such as TNF-α, IL-1β and IL-6, inflammatory granulomas and free
radical release . This action is obtained at doses lower than those necessary to obtain an
antibiotic effect. Another possible action of tetracyclines is their ability to chelate zinc
from matrix metalloproteinases (MMPS). The coronavirus family is known to bind to host MMPs,
particularly for viral survival. Their chelating activity may help inhibit SARS-CoV-2
infection by limiting its ability to replicate in the host. Finally, tetracyclines could have
a direct action by inhibiting the replication of single-stranded RNA virus, such as the
SARS-CoV-2 coronavirus.We therefore propose a larger comparative study using data from the
French National Health Data System.
Description:
DOXY-COVID study is a national, observational, retrospective cohort study to compare the risk
of severe COVID-19 in doxycycline-treated patients versus non-doxycycline-treated control
patients (so-called case-cohort study).
The patient inclusion period corresponds to the main waves associated with the COVID-19
epidemic in France, i.e. from January 1, 2020 to November 30, 2021. Indeed, the time of data
access, expected during 2022, would not allow reasonable follow-up of doxycycline-exposed
patients from December 1, 2021.
Data of interest collected on these patients are requested over the period from January 1,
2016, through December 31, 2021:
- From January 1, 2016, in order to be able to define a pre-exposure phenotype over a
follow-up period of at least 4 years in the French Health Insurance databases (period
2016-2019 inclusive)
- Until December 31, 2021, in order to have at least one month's hindsight on the risk of
occurrence of severe forms of COVID-19
