Phase III trial of inhaled SNG001 compared to placebo for the treatment of patients hospitalised due to moderate COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN85436698
- Lead Sponsor
- Synairgen Research Ltd
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36994453/ (added 31/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 623
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
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-ß 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> 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<br> 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<br> 3. Death, defined by the OSCI score of 8 (death) within 35 days of first dose<br>