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
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, INTERFERON, NEBULIZATION
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.
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 0
oxygen requirement score at day 15
oxygen requirement score at day 15
Variation oxygen requirement score between day 0 and day15
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
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Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
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