EUCTR2020-004743-83-ITActive, not recruitingPhase 1
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 - SPRINTER
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Synairgen Research Limited
- Enrollment
- 610
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 SARSCoV-
- •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. 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 IFNß1a/
- •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
- •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 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
- •Women <50 years old would be considered post-menopausal if they
- •have been amenorrhoeic for 12 months or more following cessation of
- •hormonal treatment and if follicle stimulating hormone (FSH) levels are
- •in the postmenopausal range.
- •Women =50 years old would be considered post-menopausal if they
- •have been amenorrhoeic for 12 months or more following cessation of all
- +10 more not shown
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-ß or to any
- •of the excipients in the drug preparation.
- •11. Females who are breast-feeding, lactating, pregnant or intending to
- •become pregnant.
- •12. Previous SARS-CoV-2 vaccination.
Investigators
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