Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

NCT04732949

Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19

COMPLETED PHASE3

Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection

NCT04385095

SARS-CoV-2

COMPLETED PHASE2

Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

NCT04860518

Covid19

TERMINATED PHASE2

Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients

NCT04293887

COVID-19 Recombinant Human Interferon α1β

UNKNOWN EARLY_PHASE1

Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients

NCT04449380

COVID-19 Virus Infection

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 INTERFERON NEBULIZATION

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inhaled IFN arm

IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)

Group Type EXPERIMENTAL

inhaled type I interferon

Intervention Type DRUG

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.

Control Arm:

Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).

Group Type ACTIVE_COMPARATOR

WFI water nebulization

Intervention Type DRUG

The interventional arm includes a WFI water nebulization comparator.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

WFI water nebulization

The interventional arm includes a WFI water nebulization comparator.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No