Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >2) Non-invasive ventilation or high-flow oxygen (OSCI score of 5) <br/ > <br/ >3) Mechanical ventilation (continuous or intermittent continuous positive airway pressure or intubation) or admission to intensive care (OSCI score of � 6) <br/ > <br/ >4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >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 <br/ > <br/ >6) Participation in previous clinical trials of SNG001 <br/ > <br/ >7) 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 <br/ > <br/ >8) Inability to use a nebuliser with a mouthpiece <br/ > <br/ >9) Inability to comply with the requirements for storage conditions of study medication in the home setting <br/ > <br/ >10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation <br/ > <br/ >11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant <br/ > <br/ >12) Previous SARS-CoV-2 vaccination

1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >2) Non-invasive ventilation or high-flow oxygen (OSCI score of 5) <br/ > <br/ >3) Mechanical ventilation (continuous or intermittent continuous positive airway pressure or intubation) or admission to intensive care (OSCI score of � 6) <br/ > <br/ >4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >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 <br/ > <br/ >6) Participation in previous clinical trials of SNG001 <br/ > <br/ >7) 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 <br/ > <br/ >8) Inability to use a nebuliser with a mouthpiece <br/ > <br/ >9) Inability to comply with the requirements for storage conditions of study medication in the home setting <br/ > <br/ >10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation <br/ > <br/ >11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant <br/ > <br/ >12) Previous SARS-CoV-2 vaccination

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

May 27, 2021, 12:45 a.m. oms

1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >2) Non-invasive ventilation or high-flow oxygen (OSCI score of 5) <br/ > <br/ >3) Mechanical ventilation (continuous or intermittent continuous positive airway pressure or intubation) or admission to intensive care (OSCI score of � 6) <br/ > <br/ >4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >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 <br/ > <br/ >6) Participation in previous clinical trials of SNG001 <br/ > <br/ >7) 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 <br/ > <br/ >8) Inability to use a nebuliser with a mouthpiece <br/ > <br/ >9) Inability to comply with the requirements for storage conditions of study medication in the home setting <br/ > <br/ >10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation <br/ > <br/ >11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant <br/ > <br/ >12) Previous SARS-CoV-2 vaccination

1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >2) Non-invasive ventilation or high-flow oxygen (OSCI score of 5) <br/ > <br/ >3) Mechanical ventilation (continuous or intermittent continuous positive airway pressure or intubation) or admission to intensive care (OSCI score of � 6) <br/ > <br/ >4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay <br/ > <br/ >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 <br/ > <br/ >6) Participation in previous clinical trials of SNG001 <br/ > <br/ >7) 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 <br/ > <br/ >8) Inability to use a nebuliser with a mouthpiece <br/ > <br/ >9) Inability to comply with the requirements for storage conditions of study medication in the home setting <br/ > <br/ >10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation <br/ > <br/ >11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant <br/ > <br/ >12) Previous SARS-CoV-2 vaccination