COVID-19, INTERFERON, NEBULIZATION
Conditions
Keywords
COVID-19, INTERFERON, NEBULIZATION
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 .
Interventions
DRUGinhaled 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.
DRUGWFI water nebulization
The interventional arm includes a WFI water nebulization comparator.
Sponsors
CH TOURCOING
CH ARROND DE MONTREUIL
CH SAINT-QUENTIN
CH Compiègne
CH Abbeville
CH VALENCIENNES
Clinique Teissier
University Hospital, Toulouse
University Hospital, Angers
CHU CAEN
Nantes University Hospital
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxygen requirement score at day 0 | day 0 | oxygen requirement score at day 0 |
| oxygen requirement score at day 15 | day 15 | oxygen requirement score at day 15 |
| Variation oxygen requirement score between day 0 and day15 | at day 15 | Variation oxygen requirement score between day 0 and day15 |
Countries
France
Outcome results
None listed