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

NCT04732949 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: SG0182020-004743-83
• Study Type: interventional
• Target: 623
• Locations: 17 countries
• Sites: 112

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19

Keywords

Coronavirus disease-2019 (COVID-19); Interferon beta

Outcome Measures

Primary Outcomes (2)

• Time to Hospital Discharge

  The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.

  Day 28

• Time to Recovery

  Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.

  Day 28

Secondary Outcomes (16)

• Number of Patients Who Progressed to Severe Disease or Death

  Until Day 35

• Number of Patients Who Were Intubated or Who Died

  Until Day 35

• Number of Patients Who Died Within 35 Days of First Dose

  Until Day 35 of first dose

• Cumulative Number of Patients Who Were Discharged From Hospital

  Days 7, 14, 21 and 28

• Cumulative Number of Patients With Recovery

  Days 7, 14, 21 and 28

Study Arms (2)

SNG001

ACTIVE COMPARATOR

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

Drug: SNG001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SNG001 DRUG

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

SNG001

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Synairgen Research Ltd.: lead

Study Sites (112)

The University of Arizona Medi

Tucson, Arizona, 85724, United States

Location

Professional Health Care of Pi

St. Petersburg, Florida, 33713, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Icahn School of Medicine at Mo

New York, New York, 10029-6500, United States

Location

PharmaTex Research, LLC

Amarillo, Texas, 79109, United States

Location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Ciudad Autónoma de Buenos Air, Buenos Aires, C1426BOR, Argentina

Location

Hospital Universitario Austral

Buenos Aires, B1629ODT, Argentina

Location

Hospital Papa Francisco - Hosp

Salta, 4400, Argentina

Location

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Centre Hospitalier Universitai

Brussels, 1020, Belgium

Location

UZ Brussel - Campus Jette - In

Brussels, 1090, Belgium

Location

CHR de la Citadelle - Site Cit

Liège, 4000, Belgium

Location

CHU de Liège - Domaine Univers

Liège, 4000, Belgium

Location

Instituto Mederi de Pesquisa e Saúde

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Clínica SUPERA

Chapecó, Santa Catarina, 89801-355, Brazil

Location

Sociedade Literaria e Caritativa Santo Agostinho

Criciúma, Santa Catarina, 88801-508, Brazil

Location

Instituto de Pesquisa Clínica

Campinas, São Paulo, 13060-080, Brazil

Location

Fundacao Faculdade Regional de

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Clinica de la Mujer

Bogotá, Cundinamarca, Colombia

Location

FOSCAL

Bucaramanga, Santander Department, 681004, Colombia

Location

Clinica de la Costa

Barranquilla, Colombia

Location

CHU De Nantes - Infectious Dis

Nantes, Loire-Atlantique, 44093, France

Location

CHU d'Angers

Angers, Pays de la Loire Region, 49933, France

Location

CHU de Grenoble - Hôpital Albe

La Tronche, 38700, France

Location

CHU Saint Antoine - Infectious

Paris, 75012, France

Location

Hôpital Européen Georges-Pompi

Paris, 75015, France

Location

Hopital Bichat - Infectious Di

Paris, 75018, France

Location

RoMed Medical Center Rosenheim

Rosenheim, Bavaria, 83022, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Krankenhaus Bethanien gGmbH

Solingen, 42699, Germany

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Unity Hospital

Surat, Gujarat, 395010, India

Location

Rhythm Heart Institute

Vadodara, Gujarat, 390022, India

Location

Bangalore Medical College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MS Ramaiah Medical College and Hospital

Bangalore, Karnataka, 560054, India

Location

Oriion Citicare Super Speciality Hospital - Intern

Aurangabad, Maharashtra, 431005, India

Location

Fortis Hospital Mulund - Inter

Mumbai, Maharashtra, 400078, India

Location

Government Medical College Nag

Nagpur, Maharashtra, 440003, India

Location

Suyog Hospital

Nashik, Maharashtra, 422003, India

Location

Vishwa Raj Hospital

Pune, Maharashtra, 412201, India

Location

Acharya Vinoba Bhave Rural Hos

Wardha, Maharashtra, 442004, India

Location

Post Graduate Institute of Medical Education & Research, Chandigarh

Chandigarh, Punjab, 160012, India

Location

Saveetha Medical College & Hospital

Chennai, 602105, India

Location

Assuta Ashdod University Hospi

Ashdod, Southern District, 7747629, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Ziv Medical Center

Safed, 131001, Israel

Location

Sourasky Tel Aviv Medical Cent

Tel Aviv, 6423906, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 7030000, Israel

Location

Azienda Socio Sanitaria Territ

Monza, Lombardy, 20900, Italy

Location

Azienda Ospedaliera Nazionale

Alessandria, 15100, Italy

Location

PO A.Manzoni di Lecco, ASST Le

Lecco, 23900, Italy

Location

Ospedale Luigi Sacco, AO-PU

Milan, 20157, Italy

Location

Azienda Ospedaliera Ospedale N

Milan, 20162, Italy

Location

AOU Federico II - Malattie Inf

Napoli, 80131, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

AOU Pisana

Pisa, 54124, Italy

Location

Città della Salute e della Scienza

Torino, 10139, Italy

Location

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

Monterrey, Nuevo León, 64710, Mexico

Location

Hospital General de Culiacan D

Culiacán, Sinaloa, 80230, Mexico

Location

EME RED Hospitalaria - COVID-1

Mérida, Yucatán, 97000, Mexico

Location

Hospital General Regional O´Hu

Mérida, Yucatán, 97000, Mexico

Location

Clínica Sociedad Española de Beneficencia

Veracruz, 91700, Mexico

Location

Ziekenhuis St Jansdal

Harderwijk, Gelderland, 3844 DG, Netherlands

Location

Gelre Ziekenhuis Zutphen

Zutphen, Gelderland, 7207 AE, Netherlands

Location

Isala Klinieken

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Hospital Garcia da Orta, E.P.E

Almada, Lisbon District, 2805-267, Portugal

Location

C.H. de Vila Nova de Gaia/Espi

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital da Senhora de Oliveir

Guimarães, 4835-044, Portugal

Location

Centro Hospitalar de Entre Dou

Rodrigues, 4520-211, Portugal

Location

Sp. Clinic Boli Infectioase si

Timișoara, Timiș County, 300310, Romania

Location

Spitalul Universitar de Urgent

Bucharest, 011461, Romania

Location

Sp. Cl. de Boli Infectioase si

Bucharest, 030303, Romania

Location

Spitalul Clinic de Boli Infect

Craiova, 200446, Romania

Location

Clinical Center Nis

Niš, Nišavski Okrug, 18000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

The Institute for Pulmonary Di

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac, Cl

Kragujevac, 34000, Serbia

Location

CHU A Coruña

Madrid, A Coruña, 15006, Spain

Location

Hospital Universitario Son Esp

Palma de Mallorca, Balearic Islands, 7120, Spain

Location

Hospital Universitario Mutua d

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario de Puer

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Infanta

Madrid, 28031, Spain

Location

Hospital Universitario Ramón y

Madrid, 28034, Spain

Location

H.Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de Sala

Salamanca, 37007, Spain

Location

H U Nuesta Señora de Valme - I

Seville, Spain

Location

Wexham Park Hospital

Slough, Bracknell Forest, SL2 4HL, United Kingdom

Location

Hull Royal Infirmary

Hull, North Humberside, East Riding Of Yorkshire, HU3 2RW, United Kingdom

Location

Newcastle University - Institute of Cellular Medicine (ICM)

Newcastle, England, NE2 4HH, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Churchill Hospital

Headington, Oxfordshire, OX3 9DU, United Kingdom

Location

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

The Royal Bournemouth & Christ

Bournemouth, BH7 7DP, United Kingdom

Location

University Hospital of North D

Durham, DH1 5TW, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, EX25DW, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

University Hospital Lewisham

London, SE13 6LH, United Kingdom

Location

Guy's Hospital

London, SE19RT, United Kingdom

Location

North Manchester General Hospi

Manchester, M8 5RB, United Kingdom

Location

The James Cook University Hosp

Middlesbrough, TS4 3BW, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG51PB, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

Morriston Hospital Swansea NHS

Swansea, SA6 6NL, United Kingdom

Location

University Hospital of Wales

Swansea, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Brooke Clarke, SVP, Head of Communications
• Organization: Synairgen

info@synairgen.com

02380 512 800

Study Officials

• Professor Tom Wilkinson

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: January 12, 2021
• Primary Completion: December 15, 2021
• Study Completion: February 10, 2022
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2021-01

Locations

IL (6); SE (5); FR (6); NL (3); DE (3); IN (13); CO (3); GB (20); PT (5); US (6); BE (5); RO (4); ME (5); AR (3); IT (9); ES (10); BR (6)