Retrospective Study for Identificatiopn of a Link Between Doxycycline and COVID-19 Treatment

NCT05445479 | Withdrawn FDA Drug

• 1 other identifier: AP_BD_001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Doxycycline; Treatment

Outcome Measures

Primary Outcomes (1)

• Number of hospitalization associated with COVID-19

  January 1, 2020 to November 30, 2021

Interventions

Doxycycline DRUG

Patient with doxycycline treatment during COVID-19 waves

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases are patients with data in the Medicare databases for whom at least one dispensing of doxycycline is identified during the period from January 1, 2020, to December 1, 2021. Patients included as cases are all patients identified in the Assurance Maladie databases as having been reimbursed for at least one oral doxycycline dosage form during the period of interest.

You may qualify if:

• Male or female, ≥ 12 years old
• Affiliated with the French social security system or equivalent system
• Having been dispensed oral doxycycline at a dose of 100 mg between January 1, 2020 and November 30, 2021

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

COVID-19

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share