COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Interferon beta-1a (IFN-ß1a)
Product Code: SNG001
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Interferon beta-1a
Current Sponsor code: SNG001
Concentration unit: milli
Sponsors
Synairgen Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 (e.g. RT-PCR). 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. Provide informed consent. 6. Female patients must be =1 year post-menopausal, surgically sterile, or using a highly effective method of contraception. Acceptable highly effective methods of contraception include; • bilateral tubal occlusion • intrauterine device (provided coils are copper-banded) • levonorgestrel intrauterine system (e.g., Mirena™) • medroxyprogesterone injections (e.g., Depo-Provera™) • etonogestrel implants (e.g., Implanon™, Norplan™) • normal and low dose combined oral pills • norelgestromin/ ethinylestradiol transdermal system • intravaginal device (e.g., ethinylestradiol and etonogestrel), desogestrel (e.g., Cerazette™) • total sexual abstinence (defined as refraining from heterosexual intercourse) • vasectomised sexual partner. Women 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 IFN-ß1a/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in UK 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-ß1a/matching placebo to prevent pregnancy. 7. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal 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 =65 years) yes F.1.
Exclusion criteria
Exclusion criteria: 1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay e.g. RT-PCR test. 2. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care. 3. Previous SARS-CoV-2 infection confirmed by a validated molecular assay e.g. RT-PCR test. 4. Any condition, including findings in the patient’s 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. 5. Participation in previous clinical trials of SNG001. 6. 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. 7. Inability to use a nebuliser with a mouthpiece. 8. Inability to comply with the requirements for storage conditions of study medication in the home setting. 9. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation. 10. Females who are breast-feeding, lactating, pregnant or intending to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo. ;Secondary Objective: To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a range of endpoints. To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19. ;Primary end point(s): Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments. ;Timepoint(s) of evaluation of this end point: OSCI assessments will be conducted daily between day 1 and day 35. Time to recovery will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: a. Progression to severe disease or death, defined by the OSCI score of 5 or above within 28 days of first dose. b. Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments. Secondary Endpoints: a. Progression to intubation or death, defined by the OSCI score of 6 or above within 28 days of first dose. b. Death within 28 days of first dose. c. Recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments, at Days 7, 14, 21 and 28. d. Hospital discharge at Days 7, 14, 21 and 28. e. Improvement across the entire OSCI at Days 7, 14, 21 and 28. f. Changes in breathlessness, cough and sputum scale (BCSS) score during the study period, including disaggregated breathlessness and cough scores. g. Changes in National Early Warning Score 2 (NEWS2) during the hospitalisation period. h. Quality of life measured using EQ-5D-5L. i. Long-COVID-19 symptoms. j. Safety and tolerability – vital signs, AEs and concomitant medications. ;Timepoint(s) of evaluation of this end point: Key secondary endpoints Progression to severe disease or death will be assessed using all post-baseline OSCI assessments up to day 28. Time to hospital discharge will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only. For Secondary endpoints the timepoints for evaluation are stated in the endpoint wording as per questions E5-2. | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, India, Israel, Italy, Mexico, Moldova, Republic of, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactSophie Hemmings
Synairgen Research Ltd
Outcome results
None listed