Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study (NCT04469491) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study
France74 participantsStarted 2020-09-20
Plain-language 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 .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
oxygen requirement score at day 0
Timeframe: day 0
2
oxygen requirement score at day 15
Timeframe: day 15
3
Variation oxygen requirement score between day 0 and day15