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

Study acronym: COV-NI
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion date: Sep 2025 to Dec 2025v13
  2. Trial status: Completed to Active, Not Recruiting
    • Enrollment target: 75 to 74
    • Study completion date: Sep 12, 2023 to Sep 2025
    • Collaborators expanded, about 32 words
    v12
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 2024 to Sep 12, 2023
    v11
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 146 to confirmed 75
    • Primary completion date changed from estimate of Sep 2023 to Jun 16, 2023
    • Site details revised at 7 of 7 sites
    v10
  5. Primary completion date: Mar 2023 to Sep 2023
    • Study completion date: Mar 2023 to Mar 2024
    v9
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  1. Primary and study completion dates: Mar 2022 to Mar 2023v8
  2. Primary and study completion dates: Sep 2021 to Mar 2022v7
  3. Trial status: Suspended to Recruiting
    • Site details revised at 7 of 7 sites
    v6
  4. Enrollment target: 60 to 146
    • Study sites: 1 to 7
    • Primary and study completion dates: Apr 2021 to Sep 2021
    • Eligibility criteria expanded, about 108 words
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Trial status: Recruiting to Suspended Sponsor's reason: In anticipation for Data and Safety Monitoring Board
    • Site details revised
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Mar 2021 to Apr 2021
    • Start date changed from estimate of Jul 2020 to Sep 20, 2020
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 .
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
(from sponsor)		 COVID-19, INTERFERON, NEBULIZATION
Related terms COVID-19
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov