Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469491
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 20, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

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.




Primary Outcome Measures :
  1. oxygen requirement score at day 0 [ Time Frame: day 0 ]
    oxygen requirement score at day 0

  2. oxygen requirement score at day 15 [ Time Frame: day 15 ]
    oxygen requirement score at day 15

  3. Variation oxygen requirement score between day 0 and day15 [ Time Frame: at day 15 ]
    Variation oxygen requirement score between day 0 and day15



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469491


Contacts
Layout table for location contacts
Contact: Jean-Philippe Lanoix, MD (33)322668813 lanoix.jean-philippe@chu-amiens.fr
Contact: Aurélien Mary, MD (33)22087140 mary.aurelien@chu-amiens.fr

Locations
Layout table for location information
France
CH d'Abbeville Not yet recruiting
Abbeville, France, 80142
Contact: Olivier LELEU, MD         
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Jean-Philippe Lanoix, MD    (33)3 22 66 88 13    lanoix.jean-philippe@chu-amiens.fr   
Principal Investigator: Aurélien Mary, MD         
Sub-Investigator: Michel Brazier, Pr         
Sub-Investigator: Jean Luc Jean Luc Schmit, Pr         
CH Compiègne-Noyon Not yet recruiting
Compiegne, France, 60200
Contact: Anne-Lise LECAPITAINE, MD         
CH de l'Arrondissement de Montreuil-sur-mer Not yet recruiting
Rang-du-Fliers, France, 62180
Contact: Chandra ADJODAH, MD         
CH de Saint-Quentin Not yet recruiting
Saint-Quentin, France, 02100
Contact: Houcine BENTAYEB         
CH de Tourcoing Not yet recruiting
Tourcoing, France, 59208
Contact: Eric SENEVILLE, MD         
CH de valenciennes Not yet recruiting
Valenciennes, France, 59322
Contact: Hatem BOUGHANMI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe Lanoix, MD CHU Amiens
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04469491    
Other Study ID Numbers: PI2020_843_0041
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
COVID-19
INTERFERON
NEBULIZATION
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Interferons
Interferon Type I
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents