COVID-19Phase 2COV-NINCT04469491
Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
A Phase 2 study testing inhaled type I interferon and WFI water nebulization in people with COVID-19 and INTERFERON, run by Centre Hospitalier Universitaire, Amiens at 7 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, INTERFERON, NEBULIZATION
- What is being tested?
- inhaled type I interferon and WFI water nebulization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 7 sitesFrance
- Study dates
- 20 Sep 2020to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH d'Abbeville
Abbeville, 80142
CHU Amiens
Amiens, 80480
CH Compiègne-Noyon
Compiègne, 60200
CH de l'Arrondissement de Montreuil-sur-mer
Rang-du-Fliers, 62180
CH de Saint-Quentin
Saint-Quentin, 02100
CH de Tourcoing
Tourcoing, 59208
CH de valenciennes
Valenciennes, 59322
About this study
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 .
- Conditions
- COVID-19, INTERFERON, NEBULIZATION
- Being tested
- inhaled type I interferon, WFI water nebulization
- Keywords
- COVID-19, INTERFERON, NEBULIZATION
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled type I interferonDrug
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.
WFI water nebulizationDrug
The interventional arm includes a WFI water nebulization comparator.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled IFN arm | Experimental | IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support) Receives: Drug: inhaled type I interferon |
| Control Arm: | Active comparator | Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support). Receives: Drug: WFI water nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen requirement score at day 0
oxygen requirement score at day 0
Measured: day 0
oxygen requirement score at day 15
oxygen requirement score at day 15
Measured: day 15
Variation oxygen requirement score between day 0 and day15
Variation oxygen requirement score between day 0 and day15
Measured: at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start20 Sep 2020
- Primary completion16 Jun 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- CH TOURCOING, CH ARROND DE MONTREUIL, CH SAINT-QUENTIN, Centre Hospitalier Intercommunal de Compiègne-Noyon, Abbeville Hospital Center, CH VALENCIENNES, Clinique Teissier, University Hospital, Toulouse, University Hospital, Angers, University Hospital, Caen, Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lanoix, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469491
- Sponsor's protocol ID
- PI2020_843_0041
- Acronym
- COV-NI
- Status last verified
- Nov 2025
- First submitted
- 13 Jul 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
- ClinicalTrials.gov ID
- NCT04469491
- Acronym / sponsor ID
- COV-NI / PI2020_843_0041
- Conditions
- COVID-19, INTERFERON, NEBULIZATION
- Keywords
- COVID-19, INTERFERON, NEBULIZATION
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- CH TOURCOING, CH ARROND DE MONTREUIL, CH SAINT-QUENTIN, Centre Hospitalier Intercommunal de Compiègne-Noyon, Abbeville Hospital Center, CH VALENCIENNES, Clinique Teissier, University Hospital, Toulouse, University Hospital, Angers, University Hospital, Caen, Nantes University Hospital
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled IFN arm | Experimental | Drug: inhaled type I interferonIFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support) |
| Control Arm: | Active comparator | Drug: WFI water nebulizationAerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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.
Key exclusion criteria (15 listed)
- Hypersensitivity to natural or recombinant interferon-ß
- Hypersensitivity to human albumin or mannitol
- Recent suicide attempt
- Decompensation of liver failure
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled type I interferonThe 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 | Inhaled IFN arm |
| WFI water nebulizationThe interventional arm includes a WFI water nebulization comparator. | Drug | Control Arm: |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Lanoix, MD principal investigator
CHU Amiens
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled type I interferon and WFI water nebulization in people with COVID-19 and INTERFERON, run by Centre Hospitalier Universitaire, Amiens at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen requirement score at day 0 (time frame: day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.