A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 610

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
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 informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 305
F.1.3 Elderly (>=65 years) yes
F

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19

Recruitment & Eligibility

Study & Design

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