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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04469491

Collaborator

(none)

146

Enrollment

Locations

Arms

17.3

Anticipated Duration (Months)

20.9

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
COVID-19 INTERFERON NEBULIZATION	Drug: inhaled type I interferon Drug: WFI water nebulization	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 20, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inhaled IFN arm IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)	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.
Active Comparator: Control Arm: Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).	Drug: WFI water nebulization The interventional arm includes a WFI water nebulization comparator.

Arm

Intervention/Treatment

Experimental: Inhaled IFN arm

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

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.

Active Comparator: Control Arm:

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

Drug: WFI water nebulization

The interventional arm includes a WFI water nebulization comparator.

Outcome Measures

Primary Outcome Measures

oxygen requirement score at day 0 [day 0]
oxygen requirement score at day 0
oxygen requirement score at day 15 [day 15]
oxygen requirement score at day 15
Variation oxygen requirement score between day 0 and day15 [at day 15]
Variation oxygen requirement score between day 0 and day15

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 <

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH d'Abbeville	Abbeville	France	80142
2	CHU Amiens	Amiens	France	80480
3	CH Compiègne-Noyon	Compiegne	France	60200
4	CH de l'Arrondissement de Montreuil-sur-mer	Rang-du-Fliers	France	62180
5	CH de Saint-Quentin	Saint-Quentin	France	02100
6	CH de Tourcoing	Tourcoing	France	59208
7	CH de valenciennes	Valenciennes	France	59322