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

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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

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 14, 2020
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE September 20, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • oxygen requirement score at day 0 [ Time Frame: day 0 ]
    oxygen requirement score at day 0
  • oxygen requirement score at day 15 [ Time Frame: day 15 ]
    oxygen requirement score at day 15
  • Variation oxygen requirement score between day 0 and day15 [ Time Frame: at day 15 ]
    Variation oxygen requirement score between day 0 and day15
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
Official Title  ICMJE Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • INTERFERON
  • NEBULIZATION
Intervention  ICMJE
  • 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.
  • Drug: WFI water nebulization
    The interventional arm includes a WFI water nebulization comparator.
Study Arms  ICMJE
  • Experimental: Inhaled IFN arm
    IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)
    Intervention: Drug: inhaled type I interferon
  • Active Comparator: Control Arm:
    Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).
    Intervention: Drug: WFI water nebulization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)
146
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2020)
60
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Philippe Lanoix, MD (33)322668813 lanoix.jean-philippe@chu-amiens.fr
Contact: Aurélien Mary, MD (33)22087140 mary.aurelien@chu-amiens.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04469491
Other Study ID Numbers  ICMJE PI2020_843_0041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Philippe Lanoix, MD CHU Amiens
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP