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

NCT04469491 | Active Not Recruiting Phase 2

• 1 other identifier: PI2020_843_0041
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 7

Brief 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 .

Conditions

COVID-19; INTERFERON; NEBULIZATION

Keywords

COVID-19; INTERFERON; NEBULIZATION

Outcome Measures

Primary Outcomes (3)

• oxygen requirement score at day 0

  oxygen requirement score at day 0

  day 0

• oxygen requirement score at day 15

  oxygen requirement score at day 15

  day 15

• Variation oxygen requirement score between day 0 and day15

  Variation oxygen requirement score between day 0 and day15

  at day 15

Study Arms (2)

Inhaled IFN arm

EXPERIMENTAL

IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)

Drug: inhaled type I interferon

Control Arm:

ACTIVE COMPARATOR

Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).

Drug: WFI water nebulization

Interventions

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.

Inhaled IFN arm

WFI water nebulization DRUG

The interventional arm includes a WFI water nebulization comparator.

Control Arm:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• CH TOURCOING: collaborator
• CH ARROND DE MONTREUIL: collaborator
• CH SAINT-QUENTIN: collaborator
• CH Compiègne: collaborator
• CH Abbeville: collaborator
• CH VALENCIENNES: collaborator
• Clinique Teissier: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Angers: collaborator
• CHU CAEN: collaborator
• Nantes University Hospital: collaborator

Study Sites (7)

CH d'Abbeville

Abbeville, 80142, France

Location

CHU Amiens

Amiens, 80480, France

Location

CH Compiègne-Noyon

Compiègne, 60200, France

Location

CH de l'Arrondissement de Montreuil-sur-mer

Rang-du-Fliers, 62180, France

Location

CH de Saint-Quentin

Saint-Quentin, 02100, France

Location

CH de Tourcoing

Tourcoing, 59208, France

Location

CH de valenciennes

Valenciennes, 59322, France

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Jean-Philippe Lanoix, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 14, 2020
• Study Start: September 20, 2020
• Primary Completion: June 16, 2023
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)