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.
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.
Drug: SNG001
SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day
Drug: Placebo
Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution
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.
The University of Arizona Medi
Tucson, Arizona, United States
Professional Health Care of Pi
Saint 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
UZ Brussel - Campus Jette - In
Brussel, Belgium
Centre Hospitalier Universitai
Bruxelles, 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
Chapeco, 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, Colombia
Clinica de la Costa
Barranquilla, Colombia
CHU De Nantes - Infectious Dis
Nantes, Loire-Atlantique, France
CHU d'Angers
Angers, Pays-de-la-Loire, 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, Bayern, 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, HaDarom, Israel
Rambam Health Care Campus
Haifa, Israel
Ziv Medical Center
Safed, Israel
The Chaim Sheba Medical Center
Tel Hashomer, Israel
Sourasky Tel Aviv Medical Cent
Tel-Aviv, Israel
Assaf Harofeh Medical Center
Zerifin, Israel
Azienda Socio Sanitaria Territ
Monza, Lombardia, Italy
Azienda Ospedaliera Nazionale
Alessandria, Italy
PO A.Manzoni di Lecco, ASST Le
Lecco, Italy
Ospedale Luigi Sacco, AO-PU
Milano, Italy
Azienda Ospedaliera Ospedale N
Milano, 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
Culiacan, Sinaloa, Mexico
EME RED Hospitalaria - COVID-1
Merida, Yucatán, Mexico
Hospital General Regional O´Hu
Merida, 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, Lisboa, Portugal
C.H. de Vila Nova de Gaia/Espi
Vila Nova de Gaia, Porto, 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
Timisoara, Timis, Romania
Spitalul Universitar de Urgent
Bucuresti, Romania
Sp. Cl. de Boli Infectioase si
Bucuresti, Romania
Spitalul Clinic de Boli Infect
Craiova, Romania
Clinical Center Nis
Nis, Nišavski Okrug, Serbia
Clinical Center of Vojvodina
Novi Sad, Vojvodina, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Clinical Center Kragujevac, Cl
Kragujevac, Serbia
The Institute for Pulmonary Di
Sremska Kamenica, Serbia
CHU A Coruña
Madrid, A Coruña, Spain
Hospital Universitario Son Esp
Palma De Mallorca, Baleares, 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
Sevilla, 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
Professor Tom Wilkinson, Principal Investigator
University Hospital Southampton NHS Foundation Trust