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

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

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.

Sponsors & Collaborators

• CH TOURCOING

  collaborator UNKNOWN

• CH ARROND DE MONTREUIL

  collaborator UNKNOWN

• CH SAINT-QUENTIN

  collaborator UNKNOWN

• CH Compiègne

  collaborator UNKNOWN

• CH Abbeville

  collaborator UNKNOWN

• CH VALENCIENNES

  collaborator UNKNOWN

• Clinique Teissier

  collaborator UNKNOWN

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• CHU CAEN

  collaborator UNKNOWN

• Nantes University Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Principal Investigators

• Jean-Philippe Lanoix, MD · CHU Amiens

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-20

Primary Completion

2023-06-16

Completion

2025-12-31

Countries

• France

Study Locations