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NCT Number: NCT04469491

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

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 .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CH d'Abbeville, Abbeville, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Patient with laboratory-confirmed SARS-CoV-2 infection as determined by PCR < 96 h (at initial diagnosis or persistent carriage <96 h)
  • Hospitalized patient with COVID-19 requiring oxygen therapy

And targeting in phase B :

  • Patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation with paO2/FiO2 > 200 mmHg.
  • Patients hospitalized for less than 7 days.
  • Patients with symptoms for less than 10 days or RT-PCR (<96h) with Cycle Treshold < 25.
  • Social security coverage
  • signed informed consent (by patient or their legally authorized representative)

Exclusion criteria

  • Hypersensitivity to natural or recombinant interferon-ß
  • Hypersensitivity to human albumin or mannitol
  • Recent suicide attempt
  • Decompensation of liver failure
  • age < 18 years
  • Pregnant or nursing.
  • Patients managed on an outpatient basis (i.e. not initially hospitalized).
  • Parenteral IFN treatment. In periode B, addition of new exclusion criteria
  • Patients with kidney transplant
  • Immunocompromised patients
  • Patients with severe systemic disease constantly threatening their vital prognosis (ASA ≥ IV: e.g. severe ARF, advanced cancer pathology, recent myocardial IDM, severe valvular dysfunction, dependence on parenteral nutrition on central line, shock, sepsis, trauma, ...).
  • Patients in septic shock.
  • Patients with documented fungal infection.
  • Patients on mechanical ventilation.
  • Patients hospitalized for COVID-19 for more than 7 days.

Treatment and study plan

inhaled type I interferon

Drug

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.

WFI water nebulization

Drug

The interventional arm includes a WFI water nebulization comparator.

Primary outcomes

  1. oxygen requirement score at day 0

    Time frame: day 0

    oxygen requirement score at day 0

  2. oxygen requirement score at day 15

    Time frame: day 15

    oxygen requirement score at day 15

  3. Variation oxygen requirement score between day 0 and day15

    Time frame: at day 15

    Variation oxygen requirement score between day 0 and day15

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Abbeville Hospital Center
  • CH ARROND DE MONTREUIL
  • CH SAINT-QUENTIN
  • CH TOURCOING
  • CH VALENCIENNES
  • Centre Hospitalier Intercommunal de Compiègne-Noyon
  • Clinique Teissier
  • Nantes University Hospital
  • University Hospital, Angers
  • University Hospital, Caen
  • University Hospital, Toulouse

Registry information

Acronym: COV-NI

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jul 14, 2020
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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