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

Completed · Phase 3 · Has a placebo group

Conditions studied: Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19

In brief

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

Key facts

Study ID

NCT04732949

Run by

Synairgen Research Ltd.

People needed

623

Starts

2021-01-12

Expected to finish

2022-02-10

Last updated by the study team

2023-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to hospital due to the severity of their COVID-19
• Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
• Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
• Provided informed consent
• Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
• Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy
• Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.

You may not qualify if…

• Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
• Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
• Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care
• Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
• Any condition, including findings in the patients' medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation
• Participation in previous clinical trials of SNG001
• Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study
• Inability to use a nebuliser with a mouthpiece
• Inability to comply with the requirements for storage conditions of study medication in the home setting
• History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation
• Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

Where it is running

• Professional Health Care of Pi — St. Petersburg, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Icahn School of Medicine at Mo — New York, New York, United States
• PharmaTex Research, LLC — Amarillo, Texas, United States
• Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich — Ciudad Autónoma de Buenos Air, Buenos Aires, Argentina
• Hospital Universitario Austral — Buenos Aires, Argentina
• Hospital Papa Francisco - Hosp — Salta, Argentina
• AZ Groeninge — Kortrijk, West-Vlaanderen, Belgium
• Centre Hospitalier Universitai — Brussels, Belgium
• UZ Brussel - Campus Jette - In — Brussels, Belgium
• CHR de la Citadelle - Site Cit — Liège, Belgium
• CHU de Liège - Domaine Univers — Liège, Belgium
• Instituto Mederi de Pesquisa e Saúde — Passo Fundo, Rio Grande do Sul, Brazil
• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil
• Clínica SUPERA — Chapecó, Santa Catarina, Brazil
• Sociedade Literaria e Caritativa Santo Agostinho — Criciúma, Santa Catarina, Brazil
• Instituto de Pesquisa Clínica — Campinas, São Paulo, Brazil
• Fundacao Faculdade Regional de — São José do Rio Preto, São Paulo, Brazil
• Clinica de la Mujer — Bogotá, Cundinamarca, Colombia
• FOSCAL — Bucaramanga, Santander Department, Colombia
• Clinica de la Costa — Barranquilla, Colombia
• CHU De Nantes - Infectious Dis — Nantes, Loire-Atlantique, France
• CHU d'Angers — Angers, Pays de la Loire Region, France
• The University of Arizona Medi — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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