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ACTIVE NOT RECRUITING
NCT04469491
PHASE2

Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

Summary

COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date, no treatment has yet demonstrated Strong efficacy in treating the infectious disease (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy with high potential,due to higher local concentrations and minimal adverse effects. Type I interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19 than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators have a decrease in viral carriage and a rapid reversal. The purpose of this project is to assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen requirements of the addition of inhaled Interferon type I compared to the control arm .

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2020-09-20

Completion Date

2025-12

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

DRUG

inhaled type I interferon

The interventional arm includes inhaled interferon (9.6 MUI x2/d for 48 hours, then 9.6 MUI x1/d for 8 to 16 days or discharge), in addition to standard care. In phase B, maximum treatment duration is 8 days.

DRUG

WFI water nebulization

The interventional arm includes a WFI water nebulization comparator.

Locations (7)

CH d'Abbeville

Abbeville, France

CHU Amiens

Amiens, France

CH Compiègne-Noyon

Compiègne, France

CH de l'Arrondissement de Montreuil-sur-mer

Rang-du-Fliers, France

CH de Saint-Quentin

Saint-Quentin, France

CH de Tourcoing

Tourcoing, France

CH de valenciennes

Valenciennes, France