Status:
COMPLETED
Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
Lead Sponsor:
Synairgen Research Ltd.
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS...
Detailed Description
Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 ...
Eligibility Criteria
Inclusion
- Admitted to hospital due to the severity of their COVID-19
- Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a 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 is 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 their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
- Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
- Provided informed consent
- Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
- Women of child bearing potential 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 interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom 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
- Women not of childbearing potential are defined as women who are either permanently sterilised (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 will 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 will 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.
Exclusion
- Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
- Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
- Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care
- Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
- 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
- Participation in previous clinical trials of SNG001
- Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product 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
- Inability to use a nebuliser with a mouthpiece
- Inability to comply with the requirements for storage conditions of study medication in the home setting
- History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation
- Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT04732949
Start Date
January 12 2021
End Date
February 10 2022
Last Update
March 27 2023
Active Locations (112)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Arizona Medi
Tucson, Arizona, United States, 85724
2
Professional Health Care of Pi
St. Petersburg, Florida, United States, 33713
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455