Corona virus infection: COVID19 infection
Conditions
Interventions
The treatments
If the patient qualifies to take part in this study, he/she will be assigned to
one of 2 treatment groups. For this study, we will have 2 groups:
• Treatment group 1 will receive the
Sponsors
Parexel Nederland
Eligibility
Age
12 Years to 99 Years
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 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
Exclusion criteria
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-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: a. Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments. b. Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoints: a. Progression to severe disease or death, defined by the OSCI score of 5 or above within 35 days of first dose (or randomization date if the patient not dosed). b. Progression to intubation or death, defined by the OSCI score of 6 or above within 35 days of first dose (or randomization date if the patient not dosed). c. Death within 35 days of first dose (or randomization date if the patient not dosed). Secondary Endpoints: d. 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. e. Hospital discharge by Days 7, 14, 21 and 28. f. Improvement across the entire OSCI by Days 7, 14, 21 and 28. g. Changes in breathlessness, cough and sputum scale (BCSS) score during the study period, including disaggregated breathlessness and cough scores. h. Changes in National Early Warning Score 2 (NEWS2) during the hospitalisation period. i. Daily assessment of COVID-19 symptoms and limitation of usual activities. j. Quality of life measured using EQ-5D-5L. k. Long-COVID-19 symptoms. l. Safety and tolerability - vital signs, AEs concomitant medications, and immunogenicity. | — |
Countries
Netherlands
Outcome results
None listed