Status:
ACTIVE_NOT_RECRUITING
Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
CH TOURCOING
CH ARROND DE MONTREUIL
Conditions:
COVID-19
INTERFERON
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04469491
Start Date
September 20 2020
End Date
December 1 2025
Last Update
November 19 2025
Active Locations (7)
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1
CH d'Abbeville
Abbeville, France, 80142
2
CHU Amiens
Amiens, France, 80480
3
CH Compiègne-Noyon
Compiègne, France, 60200
4
CH de l'Arrondissement de Montreuil-sur-mer
Rang-du-Fliers, France, 62180