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
- Conditions
- Corona virus infection: COVID19 infection10047438
- Registration Number
- NL-OMON51111
- Lead Sponsor
- Parexel Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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. 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-β1a/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-β1a/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
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 would 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 would 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 informe
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 breast-feeding, 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 <p>Primary Endpoints:<br /><br>a. Time to hospital discharge, defined by the OSCI score of 2 or below, with no<br /><br>rebound at subsequent assessments.<br /><br>b. Time to recovery, where recovery is defined as the OSCI score of 1 or below,<br /><br>with no<br /><br>rebound at subsequent assessments.</p><br>
- Secondary Outcome Measures
Name Time Method