Clinical Trial

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

Study acronym: COV-NI
Active, Not Recruiting Phase 2
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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 .
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2020-07-13; most recent amendment 2025-11-17.
Status change: Completed → Active, Not Recruiting 2025-05-23
Status change: Active, Not Recruiting → Completed 2023-09-12
Status change: Recruiting → Active, Not Recruiting 2023-06-16
Status change: Suspended → Recruiting 2021-03-03
Status change: Recruiting → Suspended 2020-10-29
Status change: Not Yet Recruiting → Recruiting 2020-10-14
Trial Details
NCT Number NCT04469491
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators: CH TOURCOING, CH ARROND DE MONTREUIL, CH SAINT-QUENTIN, Centre Hospitalier Intercommunal de Compiègne-Noyon, Abbeville Hospital Center, CH VALENCIENNES, Clinique Teissier, University Hospital, Toulouse, University Hospital, Angers, University Hospital, Caen, Nantes University Hospital
Conditions COVID-19, INTERFERON, NEBULIZATION
Enrollment 74 participants
Start Date 2020-09-20
Primary Completion 2023-06-16 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-19