Severe Acute Respiratory Syndrome Coronavirus 2Phase 3SPRINTERNCT04732949
Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
A Phase 3 study testing SNG001 in people with Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19, run by Synairgen Research Ltd. at 112 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
- What is being tested?
- SNG001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 623 participants
- Where
- 112 sitesin 17 countries
- Study dates
- 12 Jan 2021to 10 Feb 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
112 sites in 17 countries.
112 sites in 17 countries
United Kingdom20 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
The Royal Bournemouth & Christ
Bournemouth, BH7 7DP
University Hospital of North D
Durham, DH1 5TW
Royal Devon & Exeter Hospital
Exeter, EX25DW
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ
Glasgow Royal Infirmary
Glasgow, G4 0SF
Churchill Hospital
Headington, Oxfordshire, OX3 9DU
Hull Royal Infirmary
Hull, North Humberside, East Riding Of Yorkshire, HU3 2RW
Glenfield Hospital
Leicester, LE3 9QP
University Hospital Lewisham
London, SE13 6LH
Guy's Hospital
London, SE19RT
North Manchester General Hospi
Manchester, M8 5RB
The James Cook University Hosp
Middlesbrough, TS4 3BW
Newcastle University - Institute of Cellular Medicine (ICM)
Newcastle, England, NE2 4HH
Nottingham University Hospital
Nottingham, NG51PB
Plymouth Hospitals NHS Trust
Plymouth, PL6 8DH
Wexham Park Hospital
Slough, Bracknell Forest, SL2 4HL
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Morriston Hospital Swansea NHS
Swansea, SA6 6NL
University Hospital of Wales
Swansea, SA6 6NL
India13 sites
Bangalore Medical College and Research Institute
Bangalore, Karnataka, 560002
MS Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054
Post Graduate Institute of Medical Education & Research, Chandigarh
Chandigarh, Punjab, 160012
Saveetha Medical College & Hospital
Chennai, 602105
Oriion Citicare Super Speciality Hospital - Intern
Chhatrapati Sambhajinagar, Maharashtra, 431005
Fortis Hospital Mulund - Inter
Mumbai, Maharashtra, 400078
Government Medical College Nag
Nagpur, Maharashtra, 440003
Suyog Hospital
Nashik, Maharashtra, 422003
Vishwa Raj Hospital
Pune, Maharashtra, 412201
Unity Hospital
Surat, Gujarat, 395010
Rhythm Heart Institute
Vadodara, Gujarat, 390022
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
Acharya Vinoba Bhave Rural Hos
Wardha, Maharashtra, 442004
Spain10 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08041
CHU A Coruña
Madrid, A Coruña, 15006
Hospital Universitario Infanta
Madrid, 28031
Hospital Universitario Ramón y
Madrid, 28034
H.Clinico San Carlos
Madrid, 28040
Hospital Universitario Son Esp
Palma de Mallorca, Balearic Islands, 7120
Hospital Universitario de Puer
Puerto Real, Cádiz, 11510
Hospital Universitario de Sala
Salamanca, 37007
H U Nuesta Señora de Valme - I
Seville
Hospital Universitario Mutua d
Terrassa, Barcelona, 08221
Italy9 sites
Azienda Ospedaliera Nazionale
Alessandria, 15100
PO A.Manzoni di Lecco, ASST Le
Lecco, 23900
Ospedale Luigi Sacco, AO-PU
Milan, 20157
Azienda Ospedaliera Ospedale N
Milan, 20162
Azienda Socio Sanitaria Territ
Monza, Lombardy, 20900
AOU Federico II - Malattie Inf
Naples, 80131
IRCCS Policlinico San Matteo
Pavia, 27100
AOU Pisana
Pisa, 54124
Città della Salute e della Scienza
Torino, 10139
United States6 sites
PharmaTex Research, LLC
Amarillo, Texas, 79109
Henry Ford Health System
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55455
Icahn School of Medicine at Mo
New York, New York, 10029-6500
Professional Health Care of Pi
St. Petersburg, Florida, 33713
The University of Arizona Medi
Tucson, Arizona, 85724
Brazil6 sites
Instituto de Pesquisa Clínica
Campinas, São Paulo, 13060-080
Clínica SUPERA
Chapecó, Santa Catarina, 89801-355
Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, 88801-508
Instituto Mederi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, 99010-120
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Fundacao Faculdade Regional de
São José do Rio Preto, São Paulo, 15090-000
France6 sites
CHU d'Angers
Angers, Pays de la Loire Region, 49933
CHU de Grenoble - Hôpital Albe
La Tronche, 38700
CHU De Nantes - Infectious Dis
Nantes, Loire-Atlantique, 44093
CHU Saint Antoine - Infectious
Paris, 75012
Hôpital Européen Georges-Pompi
Paris, 75015
Hopital Bichat - Infectious Di
Paris, 75018
Israel6 sites
Assuta Ashdod University Hospi
Ashdod, Southern District, 7747629
Rambam Health Care Campus
Haifa, 3109601
Ziv Medical Center
Safed, 131001
Sourasky Tel Aviv Medical Cent
Tel Aviv, 6423906
The Chaim Sheba Medical Center
Tel HaShomer, 5265601
Assaf Harofeh Medical Center
Tsrifin, 7030000
Belgium5 sites
Centre Hospitalier Universitai
Brussels, 1020
UZ Brussel - Campus Jette - In
Brussels, 1090
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
CHR de la Citadelle - Site Cit
Liège, 4000
CHU de Liège - Domaine Univers
Liège, 4000
Mexico5 sites
Hospital General de Culiacan D
Culiacán, Sinaloa, 80230
EME RED Hospitalaria - COVID-1
Mérida, Yucatán, 97000
Hospital General Regional O´Hu
Mérida, Yucatán, 97000
Fundación Santos y de la Garza Evia, I.B.P
Monterrey, Nuevo León, 64710
Clínica Sociedad Española de Beneficencia
Veracruz, 91700
Portugal5 sites
Hospital Garcia da Orta, E.P.E
Almada, Lisbon District, 2805-267
Hospital de Braga
Braga, 4710-243
Hospital da Senhora de Oliveir
Guimarães, 4835-044
Centro Hospitalar de Entre Dou
Rodrigues, 4520-211
C.H. de Vila Nova de Gaia/Espi
Vila Nova de Gaia, Porto District, 4434-502
Serbia5 sites
University Clinical Center of Serbia
Belgrade, 11000
The Institute for Pulmonary Di
Kamenitz, 21204
Clinical Center Kragujevac, Cl
Kragujevac, 34000
Clinical Center Nis
Niš, Nišavski Okrug, 18000
Clinical Center of Vojvodina
Novi Sad, Vojvodina, 21000
Romania4 sites
Spitalul Universitar de Urgent
Bucharest, 011461
Sp. Cl. de Boli Infectioase si
Bucharest, 030303
Spitalul Clinic de Boli Infect
Craiova, 200446
Sp. Clinic Boli Infectioase si
Timișoara, Timiș County, 300310
Argentina3 sites
Hospital Universitario Austral
Buenos Aires, B1629ODT
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Ciudad Autónoma de Buenos Air, Buenos Aires, C1426BOR
Hospital Papa Francisco - Hosp
Salta, 4400
Colombia3 sites
Clinica de la Costa
Barranquilla
Clinica de la Mujer
Bogotá, Cundinamarca
FOSCAL
Bucaramanga, Santander Department, 681004
Germany3 sites
Universitätsklinikum Mannheim
Mannheim, 68167
RoMed Medical Center Rosenheim
Rosenheim, Bavaria, 83022
Krankenhaus Bethanien gGmbH
Solingen, 42699
Netherlands3 sites
Ziekenhuis St Jansdal
Harderwijk, Gelderland, 3844 DG
Gelre Ziekenhuis Zutphen
Zutphen, Gelderland, 7207 AE
Isala Klinieken
Zwolle, Overijssel, 8025 AB
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
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.
Read the 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.
- Being tested
- SNG001, Placebo
- Keywords
- Coronavirus disease-2019 (COVID-19), Interferon beta
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNG001Drug
SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day
PlaceboDrug
Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution
| Study group | Role | What they receive |
|---|---|---|
| SNG001 | Active comparator | SNG001 via inhalation using Ultra device, once a day for 14 days Receives: Drug: SNG001 |
| Placebo | Placebo comparator | Placebo via inhalation using Ultra device, once a day for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hospital Discharge
The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.
Measured: 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.
Measured: Day 28
Secondary outcomes (16)
Number of Patients Who Progressed to Severe Disease or Death
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death was evaluated. Severe disease was defined by the Ordinal Scale for Clinical Improvement (OSCI) as a score between 5 and 7. Death was defined by an OSCI score of 8.
Measured: Until Day 35
Number of Patients Who Were Intubated or Who Died
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death was evaluated. Intubation was defined by the OSCI as a score between 6 and 7. Death was defined by an OSCI score of 8.
Measured: Until Day 35
Number of Patients Who Died Within 35 Days of First Dose
Patients who died within 35 days of first dose of study intervention were calculated.
Measured: Until Day 35 of first dose
Cumulative Number of Patients Who Were Discharged From Hospital
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 was assessed by hospital discharge on given days.
Measured: Days 7, 14, 21 and 28
Cumulative Number of Patients With Recovery
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery was evaluated. Recovery is defined as no limitation of activities according to the Ordinal Scale of Clinical Improvement (OSCI), with no rebound at subsequent assessments.
Measured: Days 7, 14, 21 and 28
Improvement Based on Entire WHO OSCI Score
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI were evaluated. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.Higher scores indicated worse outcome.
Measured: Until Day 35
Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)
The efficacy of SNG001 compared with placebo in patients with moderate COVID-19 by assessing changes in daily breathlessness, cough and sputum scores on a scale of 0 (no symptoms) up to 4 (severe symptoms) was evaluated. Breathlessness, Cough and Sputum is graded on a score from 0 to 4, where a higher score indicates worse symptoms. The total score is calculated by summing the individual scores and is therefore graded on a scale from 0 to 12.
Change in value of BCSS total scale, with negative value indicates an improvement in symptoms.
Measured: Baseline to Day 15
Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period was evaluated. It is the sum of scores calculated for Respiratory rate, Oxygen Saturation, Systolic BP, Pulse and Temperature when graded on a scale from 0 to 3 where 0 means a normal assessment and a higher score indicates a greater deviation from normal . 2 more points are added if the patient is receiving oxygen and 3 further points are added if the patient has new-onset confusion, disorientation and/or agitation, where previously their mental state was normal. This gives a score between 0 and 20. Higher scores indicates high clinical risk.
Change from baseline in NEWS-2 score, in negative values favors improvement.
Measured: Day 1 until Day 28
Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of COVID-19 symptoms was evaluated. The presence of COVID-19 symptoms were assessed. Individual symptoms related to COVID-19/SARS-CoV-2 infection such as fever, breathlessness, and fatigue were assessed.
Measured: Day 1 until Day 90
Number of Patients With Limitations of Usual Activities Based on Daily Assessment
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of limitation of usual activities was evaluated. The patients with limitations of usual activities were the patients who were unable to do usual activities (work, study, housework, family or leisure activities).
Measured: Day 1 until Day 35
Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by using EQ-5D-5L was evaluated. The EQ-5D-5L provides a simple descriptive profile and a single index value for health status. The EQ-5D-5L self-rated questionnaire includes a visual analogue scale, which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life. It also includes the EQ-5D-5L descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Here, 100 means the best health and 0 means the worst health.
Measured: Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90
General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score
The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms was evaluated. Assessment of long-COVID-19 symptoms based on GAD-7 scale. GAD-7 scores seven individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. The GAD-7 total score is calculated by summing the individual item scales to give a total score between 0 and 21. Higher score indicates severe anxiety.
Measured: Day 15, Day 28, Day 60 and Day 90
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score
Long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) were evaluated. The FACIT Fatigue Scale (Version 4) included statements for patients such as: I feel fatigued; I feel weak all over; I feel listless ("washed out"); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; and I am frustrated by being too tired to do the things I want to do. Based on responses on above statements, scoring was done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates very much bothered every day by any of the above problems. Total scores will be calculated as per the algorithm to give a total score on a scale between 0 and 52, where a higher total score indicates lower level of fatigue.
Measured: Day 15, Day 28, Day 60 and Day 90
Patient Health Questionnaire-9 (PHQ-9) Total Score
Long-COVID-19 symptoms based on PHQ-9 were evaluated. Patient Health Questionnaire-9 (PHQ-9) scores nine individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. PHQ-9 total scores are calculated by summing the individual item scales to give a total score between 0 and 27. Higher scores indicated worse outcome.
Measured: Day 15, Day 28, Day 60 and Day 90
Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores
Brief Pain Inventory Composite Scores is a self administered questionnaire that assesses pain interference. Overall pain severity score is calculated as the mean of questions of the brief pain inventory. The overall pain severity score is the average pain, on a scale from 0 to 10 of the worst pain, least pain and average pain in the last 24 hours and pain right now scores. Here, 0 indicates "No pain" and 10 indicates "Worst pain".
Measured: Day 15, Day 28, Day 60 and Day 90
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19 by assessing number of patients with AEs was assessed.
Measured: From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start12 Jan 2021
- Primary completion15 Dec 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synairgen Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Tom Wilkinson, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732949
- Sponsor's protocol ID
- SG018
- Other IDs
- 2020-004743-83
- Acronym
- SPRINTER
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04732949
- Acronym / sponsor ID
- SPRINTER / SG018
- Keywords
- Coronavirus disease-2019 (COVID-19), Interferon beta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Synairgen Research Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 27 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNG001 | Active comparator | Drug: SNG001SNG001 via inhalation using Ultra device, once a day for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo via inhalation using Ultra device, once a day for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNG001SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day | Drug | SNG001 |
| PlaceboPlacebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution | Drug | Placebo |
Primary outcome
Time to Hospital Discharge
Time frame: Day 28
The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.
Time to Recovery
Time frame: Day 28
Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.
16 secondary outcomes
Number of Patients Who Progressed to Severe Disease or Death
Time frame: Until Day 35
Number of Patients Who Were Intubated or Who Died
Time frame: Until Day 35
Number of Patients Who Died Within 35 Days of First Dose
Time frame: Until Day 35 of first dose
Cumulative Number of Patients Who Were Discharged From Hospital
Time frame: Days 7, 14, 21 and 28
Cumulative Number of Patients With Recovery
Time frame: Days 7, 14, 21 and 28
Improvement Based on Entire WHO OSCI Score
Time frame: Until Day 35
Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)
Time frame: Baseline to Day 15
Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period
Time frame: Day 1 until Day 28
Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment
Time frame: Day 1 until Day 90
Number of Patients With Limitations of Usual Activities Based on Daily Assessment
Time frame: Day 1 until Day 35
Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)
Time frame: Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90
General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score
Time frame: Day 15, Day 28, Day 60 and Day 90
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score
Time frame: Day 15, Day 28, Day 60 and Day 90
Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: Day 15, Day 28, Day 60 and Day 90
Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores
Time frame: Day 15, Day 28, Day 60 and Day 90
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Tom Wilkinson principal investigator
University Hospital Southampton NHS Foundation Trust
112 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SNG001 in people with Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19, run by Synairgen Research Ltd. at 112 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United Kingdom, India, Spain, Italy, United States and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hospital Discharge (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.