Phase III trial of inhaled SNG001 compared to placebo for the treatment of patients hospitalised due to moderate COVID-19
| ISRCTN | ISRCTN85436698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85436698 |
| EudraCT/CTIS number | 2020-004743-83 |
| IRAS number | 290965 |
| ClinicalTrials.gov number | NCT04732949 |
| Secondary identifying numbers | SG018, IRAS 290965, CPMS 47416, UPH |
- Submission date
- 18/01/2021
- Registration date
- 03/02/2021
- Last edited
- 31/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
SNG001 is an inhaled drug that contains interferon-β, an antiviral protein that occurs naturally in the body. Interferon-β has been given as an injection to thousands of patients for other diseases (such as multiple sclerosis); this study is about giving interferon-β by inhalation. By administering SNG001 directly into the lungs through a nebuliser (a device used to turn liquids into mists for breathing treatments), it is hoped that the interferon-β can boost the lungs’ antiviral defences and help prevent deterioration in lung symptoms and help accelerate the recovery in patients already having breathing difficulties due to COVID-19. Recent research has suggested that interferon-β, if given by inhalation, might protect the cells in the lungs from viruses.
Early in 2020, Synairgen conducted a Phase II trial on SNG001 in patients hospitalised with COVID-19. The key findings from the placebo-controlled study in 101 patients were encouraging:
1. A two-fold increase in the likelihood of recovery, defined as ‘no limitation of activities’, during the treatment period.
2. SNG001 was very well tolerated in these hospitalised patients
SNG001 is an investigational drug which means it has not been approved as a marketed product (i.e. available to be prescribed and sold) by any regulatory authority. The aim of this study is to see if SNG001 helps COVID-19 participants recover more quickly from their illness and to find out if it is safe and effective in treating moderate COVID-19 compared to placebo (dummy drug).
Who can participate?
Adults ages 18 or over who are hospitalised with moderate COVID-19 and meet the study inclusion criteria and none of the exclusion criteria.
What does the study involve?
Patients will give informed consent to participate in the study. If eligible they will be randomly allocated to be treated with either SNG001 or placebo (dummy drug) and study assessments will be performed daily until day 35 and follow-up at various times until day 90. Patients will take the study medication daily for 14 days, this could be at hospital or at home if discharged from hospital.
What are the possible benefits and risks of participating?
It is hoped that SNG001 will help improve or treat COVID-19. However, participants may not get any direct benefit from taking part in this study. They will be given close attention from the study staff during the time they are involved in the study. They may get information about their health from physical examinations and medical tests done in this study. If the results of this study are favourable and, along with extra studies, lead to approval by regulatory authorities for use in humans, there may be benefits for patients in the future.
Where is the study run from?
Synairgen Research Ltd (UK)
When is the study starting and how long is it expected to run for?
August 2020 to February 2022
Who is funding the study?
Synairgen Research Ltd (UK)
Who is the main contact?
Sophie Hemmings
info@synairgen.com
Contact information
Public
Synairgen Research Ltd
Level F (810)
South Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 512800 |
|---|---|
| info@synairgen.com |
Scientific
Synairgen Research Ltd
Level F (810)
South Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 512800 |
|---|---|
| info@synairgen.com |
Study information
| Study design | Multi-centre interventional double-blind placebo-controlled randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific 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 |
| Study acronym | SPRINTER |
| Study hypothesis | The aim of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed SARS-CoV-2. Safety and other efficacy endpoints will also be assessed. |
| Ethics approval(s) | Approved 09/11/2020, London - Riverside Research Ethics Committee (Level 3 Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8340; riverside.rec@hra.nhs.uk), REC ref: 20/HRA/5234 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | SNG001 or placebo, randomised via IWRS, 1:1 ratio. Dose: two syringes of either SNG001 (per syringe; 0.65 ml of drug product solution at a concentration of 12 MIU/ml) or placebo (per syringe; 0.65 ml of excipients only) taken once daily for 14 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | SNG001 (inhaled interferon-β) |
| Primary outcome measure | 1. Time to hospital discharge, considered when Ordinal Scale for Clinical Improvement (OSCI) score is 2 (limitation of activities) or below with no rebound at subsequent assessments, from day 1 until day 28 2. Time to recovery, defined as an OSCI score of 1 (no limitation of activities) or below with no rebound at subsequent assessments, from day 1 until day 28 |
| Secondary outcome measures | 1. Progression to severe disease or death, defined by the OSCI score of 5 (non-invasive ventilation or high-flow oxygen) or above within 35 days of first dose 2. Progression to intubation or death, defined by the OSCI score of 6 (intubation and mechanical ventilation) or above within 35 days of first dose 3. Death, defined by the OSCI score of 8 (death) within 35 days of first dose |
| Overall study start date | 13/08/2020 |
| Overall study end date | 10/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 610 |
| Total final enrolment | 623 |
| Participant inclusion criteria | 1. Male or female, ≥18 years of age at the time of consent 2. Admitted to hospital due to the severity of their COVID-19 3. Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had 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 was 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 positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection 4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4) 5. Provided informed consent 6. Female patients must be ≥1 year post-menopausal, surgically sterile, or using a highly effective method of contraception |
| Participant exclusion criteria | 1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay 2. Non-invasive ventilation or high-flow oxygen (OSCI score of 5) 3. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care (OSCI score of ≥6) 4. Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay 5. 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 6. Participation in previous clinical trials of SNG001 7. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) 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 8. Inability to use a nebuliser with a mouthpiece 9. Inability to comply with the requirements for storage conditions of study medication in the home setting 10. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation 11. Females who are breastfeeding, lactating, pregnant or intending to become pregnant 12. Previous SARS-CoV-2 vaccination |
| Recruitment start date | 12/01/2021 |
| Recruitment end date | 11/11/2021 |
Locations
Countries of recruitment
- Argentina
- Belgium
- Brazil
- Colombia
- England
- France
- Germany
- India
- Israel
- Italy
- Mexico
- Netherlands
- Portugal
- Romania
- Serbia
- Spain
- United Kingdom
- United States of America
Study participating centres
University Hospital Southampton NHS Foundation Trust
Mailpoint 218
Tremona Road
Southampton
SO16 6YD
United Kingdom
Entrance 2, 1st Floor, Daisy Building
Castle Road
Cottingham
Hull
HU16 5JQ
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sponsor information
Industry
Level F (810)
South Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 512800 |
|---|---|
| jody.brookes@synairgen.com | |
| Website | www.synairgen.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 11/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/03/2023 | 31/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
31/03/2023: Publication reference added.
11/07/2022: The overall trial end date has been changed from 11/02/2022 to 10/02/2022.
03/03/2022: The intention to publish date has been changed from 01/03/2022 to 11/02/2023.
21/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 04/01/2022 to 11/02/2022.
2. The recruitment end date was changed from 30/11/2021 to 11/11/2021.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
18/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2021 to 30/11/2021.
2. The overall end date was changed from 05/11/2021 to 04/01/2022.
3. The plain English summary was updated to reflect these changes.
20/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2021 to 01/10/2021.
2. The overall tral end date has been changed from 01/09/2021 to 05/11/2021.
25/03/2021: The NCT number has been added.
03/02/2021: Trial's existence confirmed by London - Riverside Research Ethics Committee.
