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

NCT ID: NCT04732949

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 623 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-02-10

Brief Summary

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.

Detailed Description

Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SNG001

SNG001 via inhalation using Ultra device, once a day for 14 days

Group Type: ACTIVE_COMPARATOR

SNG001

Intervention Type: DRUG

SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day

Placebo

Placebo via inhalation using Ultra device, once a day for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution

Interventions

SNG001

SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day

Intervention Type: DRUG

Placebo

Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synairgen Research Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Tom Wilkinson

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

The University of Arizona Medi

Tucson, Arizona, United States

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

CHU de Grenoble - Hôpital Albe

La Tronche, , France

CHU Saint Antoine - Infectious

Paris, , France

Hôpital Européen Georges-Pompi

Paris, , France

Hopital Bichat - Infectious Di

Paris, , France

RoMed Medical Center Rosenheim

Rosenheim, Bavaria, Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Krankenhaus Bethanien gGmbH

Solingen, , Germany

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Unity Hospital

Surat, Gujarat, India

Rhythm Heart Institute

Vadodara, Gujarat, India

Bangalore Medical College and Research Institute

Bangalore, Karnataka, India

MS Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

Oriion Citicare Super Speciality Hospital - Intern

Aurangabad, Maharashtra, India

Fortis Hospital Mulund - Inter

Mumbai, Maharashtra, India

Government Medical College Nag

Nagpur, Maharashtra, India

Suyog Hospital

Nashik, Maharashtra, India

Vishwa Raj Hospital

Pune, Maharashtra, India

Acharya Vinoba Bhave Rural Hos

Wardha, Maharashtra, India

Post Graduate Institute of Medical Education & Research, Chandigarh

Chandigarh, Punjab, India

Saveetha Medical College & Hospital

Chennai, , India

Assuta Ashdod University Hospi

Ashdod, Southern District, Israel

Rambam Health Care Campus

Haifa, , Israel

Ziv Medical Center

Safed, , Israel

Sourasky Tel Aviv Medical Cent

Tel Aviv, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Azienda Socio Sanitaria Territ

Monza, Lombardy, Italy

Azienda Ospedaliera Nazionale

Alessandria, , Italy

PO A.Manzoni di Lecco, ASST Le

Lecco, , Italy

Ospedale Luigi Sacco, AO-PU

Milan, , Italy

Azienda Ospedaliera Ospedale N

Milan, , Italy

AOU Federico II - Malattie Inf

Napoli, , Italy

IRCCS Policlinico San Matteo

Pavia, , Italy

AOU Pisana

Pisa, , Italy

Città della Salute e della Scienza

Torino, , Italy

Fundación Santos y de la Garza Evia, I.B.P

Monterrey, Nuevo León, Mexico

Hospital General de Culiacan D

Culiacán, Sinaloa, Mexico

EME RED Hospitalaria - COVID-1

Mérida, Yucatán, Mexico

Hospital General Regional O´Hu

Mérida, Yucatán, Mexico

Clínica Sociedad Española de Beneficencia

Veracruz, , Mexico

Ziekenhuis St Jansdal

Harderwijk, Gelderland, Netherlands

Gelre Ziekenhuis Zutphen

Zutphen, Gelderland, Netherlands

Isala Klinieken

Zwolle, Overijssel, Netherlands

Hospital Garcia da Orta, E.P.E

Almada, Lisbon District, Portugal

C.H. de Vila Nova de Gaia/Espi

Vila Nova de Gaia, Porto District, Portugal

Hospital de Braga

Braga, , Portugal

Hospital da Senhora de Oliveir

Guimarães, , Portugal

Centro Hospitalar de Entre Dou

Rodrigues, , Portugal

Sp. Clinic Boli Infectioase si

Timișoara, Timiș County, Romania

Spitalul Universitar de Urgent

Bucharest, , Romania

Sp. Cl. de Boli Infectioase si

Bucharest, , Romania

Spitalul Clinic de Boli Infect

Craiova, , Romania

Clinical Center Nis

Niš, Nišavski Okrug, Serbia

Clinical Center of Vojvodina

Novi Sad, Vojvodina, Serbia

University Clinical Center of Serbia

Belgrade, , Serbia

The Institute for Pulmonary Di

Kamenitz, , Serbia

Clinical Center Kragujevac, Cl

Kragujevac, , Serbia

CHU A Coruña

Madrid, A Coruña, Spain

Hospital Universitario Son Esp

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Mutua d

Terrassa, Barcelona, Spain

Hospital Universitario de Puer

Puerto Real, Cádiz, Spain

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Infanta

Madrid, , Spain

Hospital Universitario Ramón y

Madrid, , Spain

H.Clinico San Carlos

Madrid, , Spain

Hospital Universitario de Sala

Salamanca, , Spain

H U Nuesta Señora de Valme - I

Seville, , Spain

Wexham Park Hospital

Slough, Bracknell Forest, United Kingdom

Hull Royal Infirmary

Hull, North Humberside, East Riding Of Yorkshire, United Kingdom

Newcastle University - Institute of Cellular Medicine (ICM)

Newcastle, England, United Kingdom

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Churchill Hospital

Headington, Oxfordshire, United Kingdom

Frimley Park Hospital

Frimley, Surrey, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

The Royal Bournemouth & Christ

Bournemouth, , United Kingdom

University Hospital of North D

Durham, , United Kingdom

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Glenfield Hospital

Leicester, , United Kingdom

University Hospital Lewisham

London, , United Kingdom

Guy's Hospital

London, , United Kingdom

North Manchester General Hospi

Manchester, , United Kingdom

The James Cook University Hosp

Middlesbrough, , United Kingdom

Nottingham University Hospital

Nottingham, , United Kingdom

Plymouth Hospitals NHS Trust

Plymouth, , United Kingdom

Morriston Hospital Swansea NHS

Swansea, , United Kingdom

University Hospital of Wales

Swansea, , United Kingdom

Countries

United States; Argentina; Belgium; Brazil; Colombia; France; Germany; India; Israel; Italy; Mexico; Netherlands; Portugal; Romania; Serbia; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-004743-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SG018

Identifier Type: -

Identifier Source: org_study_id