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

COVID-19 Clinical Trial

— COV-NI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469491
• Other study ID #: PI2020_843_0041
• Status: Completed
• Phase: Phase 2
• Start date: September 20, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 12, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• INTERFERON
• NEBULIZATION

Intervention

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.
• WFI water nebulization
The interventional arm includes a WFI water nebulization comparator.

Locations

Country	Name	City	State
France	CH d'Abbeville	Abbeville
France	CHU Amiens	Amiens
France	CH Compiègne-Noyon	Compiegne
France	CH de l'Arrondissement de Montreuil-sur-mer	Rang-du-Fliers
France	CH de Saint-Quentin	Saint-Quentin
France	CH de Tourcoing	Tourcoing
France	CH de valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen requirement score at day 0	oxygen requirement score at day 0	day 0
Primary	oxygen requirement score at day 15	oxygen requirement score at day 15	day 15
Primary	Variation oxygen requirement score between day 0 and day15	Variation oxygen requirement score between day 0 and day15	at day 15