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

Primary Purpose

COVID-19, INTERFERON, NEBULIZATION

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

inhaled type I interferon

WFI water nebulization

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, INTERFERON, NEBULIZATION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 < 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.

Sites / Locations

CH d'Abbeville
CHU Amiens
CH Compiègne-Noyon
CH de l'Arrondissement de Montreuil-sur-mer
CH de Saint-Quentin
CH de Tourcoing
CH de valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled IFN arm

Control Arm:

Arm Description

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

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

Outcomes

Primary Outcome Measures

oxygen requirement score at day 0

oxygen requirement score at day 15

Variation oxygen requirement score between day 0 and day15

Secondary Outcome Measures

Full Information

NCT ID

NCT04469491

First Posted

July 13, 2020

Last Updated

September 12, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT04469491

Brief Title

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

Acronym

COV-NI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 20, 2020 (Actual)

Primary Completion Date

June 16, 2023 (Actual)

Study Completion Date

September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, INTERFERON, NEBULIZATION

Keywords

COVID-19, INTERFERON, NEBULIZATION

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled IFN arm

Arm Type

Experimental

Arm Description

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

Arm Title

Control Arm:

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

inhaled type I interferon

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

WFI water nebulization

Intervention Description

The interventional arm includes a WFI water nebulization comparator.

Primary Outcome Measure Information:

Title

oxygen requirement score at day 0

Description

oxygen requirement score at day 0

Time Frame

day 0

Title

oxygen requirement score at day 15

Description

oxygen requirement score at day 15

Time Frame

day 15

Title

Variation oxygen requirement score between day 0 and day15

Description

Variation oxygen requirement score between day 0 and day15

Time Frame

at day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe Lanoix, MD

Organizational Affiliation

CHU Amiens

Official's Role

Principal Investigator

Facility Information:

Facility Name

CH d'Abbeville

City

Abbeville

ZIP/Postal Code

80142

Country

France

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80480

Country

France

Facility Name

CH Compiègne-Noyon

City

Compiegne

ZIP/Postal Code

60200

Country

France

Facility Name

CH de l'Arrondissement de Montreuil-sur-mer

City

Rang-du-Fliers

ZIP/Postal Code

62180

Country

France

Facility Name

CH de Saint-Quentin

City

Saint-Quentin

ZIP/Postal Code

02100

Country

France

Facility Name

CH de Tourcoing

City

Tourcoing

ZIP/Postal Code

59208

Country

France

Facility Name

CH de valenciennes

City

Valenciennes

ZIP/Postal Code

59322

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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