Study to Assess Efficacy and Safety of Inhaled Interferon... | NCT04732949

ID	Type	Description	Link
2020-004743-83	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
SNG001	Active Comparator	SNG001 via inhalation using Ultra device, once a day for 14 days	Drug: SNG001
Placebo	Placebo Comparator	Placebo via inhalation using Ultra device, once a day for 14 days	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SNG001	Drug	SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day	SNG001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Hospital Discharge	The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.	Day 28
Time to Recovery	Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients Who Progressed to Severe Disease or Death	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death was evaluated. Severe disease was defined by the Ordinal Scale for Clinical Improvement (OSCI) as a score between 5 and 7. Death was defined by an OSCI score of 8.	Until Day 35

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Name	Affiliation	Role
Professor Tom Wilkinson	University Hospital Southampton NHS Foundation Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona Medi		Tucson	Arizona	85724	United States
Professional Health Care of Pi

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
FG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 9, 2021	Dec 14, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Hospital Discharge

The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.

The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.

Posted

Median

95% Confidence Interval

days

Day 28

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000309 OG001314

Title

Denominators

Categories

Title	Measurements
	OG0007.0(7.0 to 8.0) OG0018.0(7.0 to 9.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hazard Ratio for time to hospital discharge - SNG001 vs Placebo	Cox proportional hazard model		0.509		Hazard Ratio (HR)	1.06			2-Sided	95	0.89	1.27					Other

Primary

Time to Recovery

Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.

The ITT analysis population consisted of all randomised patients.

Posted

Median

95% Confidence Interval

days

Day 28

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Progressed to Severe Disease or Death

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death was evaluated. Severe disease was defined by the Ordinal Scale for Clinical Improvement (OSCI) as a score between 5 and 7. Death was defined by an OSCI score of 8.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Count of Participants

Participants

Until Day 35

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Were Intubated or Who Died

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death was evaluated. Intubation was defined by the OSCI as a score between 6 and 7. Death was defined by an OSCI score of 8.

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Until Day 35

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Died Within 35 Days of First Dose

Patients who died within 35 days of first dose of study intervention were calculated.

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Until Day 35 of first dose

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Cumulative Number of Patients Who Were Discharged From Hospital

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 was assessed by hospital discharge on given days.

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Days 7, 14, 21 and 28

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Cumulative Number of Patients With Recovery

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery was evaluated. Recovery is defined as no limitation of activities according to the Ordinal Scale of Clinical Improvement (OSCI), with no rebound at subsequent assessments.

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Days 7, 14, 21 and 28

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Improvement Based on Entire WHO OSCI Score

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI were evaluated. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.Higher scores indicated worse outcome.

Posted

Count of Participants

Participants

Until Day 35

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)

The efficacy of SNG001 compared with placebo in patients with moderate COVID-19 by assessing changes in daily breathlessness, cough and sputum scores on a scale of 0 (no symptoms) up to 4 (severe symptoms) was evaluated. Breathlessness, Cough and Sputum is graded on a score from 0 to 4, where a higher score indicates worse symptoms. The total score is calculated by summing the individual scores and is therefore graded on a scale from 0 to 12.

Change in value of BCSS total scale, with negative value indicates an improvement in symptoms.

The ITT analysis population consisted of all randomised patients.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline to Day 15

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants

Secondary

Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period was evaluated. It is the sum of scores calculated for Respiratory rate, Oxygen Saturation, Systolic BP, Pulse and Temperature when graded on a scale from 0 to 3 where 0 means a normal assessment and a higher score indicates a greater deviation from normal . 2 more points are added if the patient is receiving oxygen and 3 further points are added if the patient has new-onset confusion, disorientation and/or agitation, where previously their mental state was normal. This gives a score between 0 and 20. Higher scores indicates high clinical risk.

Change from baseline in NEWS-2 score, in negative values favors improvement.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 1 until Day 28

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Secondary

Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of COVID-19 symptoms was evaluated. The presence of COVID-19 symptoms were assessed. Individual symptoms related to COVID-19/SARS-CoV-2 infection such as fever, breathlessness, and fatigue were assessed.

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Day 1 until Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Number of Patients With Limitations of Usual Activities Based on Daily Assessment

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of limitation of usual activities was evaluated. The patients with limitations of usual activities were the patients who were unable to do usual activities (work, study, housework, family or leisure activities).

The ITT analysis population consisted of all randomised patients.

Posted

Count of Participants

Participants

Day 1 until Day 35

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Secondary

Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by using EQ-5D-5L was evaluated. The EQ-5D-5L provides a simple descriptive profile and a single index value for health status. The EQ-5D-5L self-rated questionnaire includes a visual analogue scale, which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life. It also includes the EQ-5D-5L descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Here, 100 means the best health and 0 means the worst health.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Secondary

General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score

The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms was evaluated. Assessment of long-COVID-19 symptoms based on GAD-7 scale. GAD-7 scores seven individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. The GAD-7 total score is calculated by summing the individual item scales to give a total score between 0 and 21. Higher score indicates severe anxiety.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 15, Day 28, Day 60 and Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts

Secondary

Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score

Long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) were evaluated. The FACIT Fatigue Scale (Version 4) included statements for patients such as: I feel fatigued; I feel weak all over; I feel listless ("washed out"); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; and I am frustrated by being too tired to do the things I want to do. Based on responses on above statements, scoring was done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates very much bothered every day by any of the above problems. Total scores will be calculated as per the algorithm to give a total score on a scale between 0 and 52, where a higher total score indicates lower level of fatigue.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 15, Day 28, Day 60 and Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo

Secondary

Patient Health Questionnaire-9 (PHQ-9) Total Score

Long-COVID-19 symptoms based on PHQ-9 were evaluated. Patient Health Questionnaire-9 (PHQ-9) scores nine individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. PHQ-9 total scores are calculated by summing the individual item scales to give a total score between 0 and 27. Higher scores indicated worse outcome.

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 15, Day 28, Day 60 and Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants

Secondary

Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores

Brief Pain Inventory Composite Scores is a self administered questionnaire that assesses pain interference. Overall pain severity score is calculated as the mean of questions of the brief pain inventory. The overall pain severity score is the average pain, on a scale from 0 to 10 of the worst pain, least pain and average pain in the last 24 hours and pain right now scores. Here, 0 indicates "No pain" and 10 indicates "Worst pain".

The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.

Posted

Mean

Standard Deviation

score on a scale

Day 15, Day 28, Day 60 and Day 90

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants

Secondary

Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)

The general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19 by assessing number of patients with AEs was assessed.

The Safety analysis population included all patients in the ITT population who receive at least one dose of study drug.

Posted

Count of Participants

Participants

From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)

ID	Title	Description
OG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
OG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG00011 events11 affected301 at risk EG0018 events8 affected303 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0008 events8 affected301 at risk EG0018 events8 affected303 at risk
Pneumonia	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0003 events3 affected301 at risk EG0010 events0 affected303 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Pneumonia acinetobacter	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Staphylococcal infection	Infections and infestations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Blood disorder	Blood and lymphatic system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Disorientation	Psychiatric disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Dysaesthesia	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Syncope	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected303 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Angina pectoris	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Cardiac arrest	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected303 at risk
Cardiac failure	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Coronary artery disease	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Myocardial infarction	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Pericarditis	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0009 events9 affected301 at risk EG0019 events9 affected303 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected303 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0017 events7 affected303 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0015 events5 affected303 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected303 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (24.1)	Non-systematic Assessment	EG0003 events3 affected301 at risk EG0012 events2 affected303 at risk
Renal failure	Renal and urinary disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected303 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Chest pain	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected303 at risk
Oxygen consumption increased	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk
Oxygen saturation decreased	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected303 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG00084 events71 affected301 at risk EG00176 events61 affected303 at risk
Anosmia	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG00018 events18 affected301 at risk EG00120 events20 affected303 at risk
Ageusia	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG00013 events13 affected301 at risk EG00119 events18 affected303 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (24.1)	Non-systematic Assessment	EG00026 events25 affected301 at risk EG0019 events9 affected303 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00078 events70 affected301 at risk EG00185 events72 affected303 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00062 events58 affected301 at risk EG00155 events54 affected303 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00057 events55 affected301 at risk EG00150 events47 affected303 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00054 events45 affected301 at risk EG00145 events35 affected303 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00046 events39 affected301 at risk EG00132 events28 affected303 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00035 events30 affected301 at risk EG00146 events41 affected303 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00016 events16 affected301 at risk EG00122 events22 affected303 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00023 events22 affected301 at risk EG00131 events26 affected303 at risk
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00023 events21 affected301 at risk EG00127 events22 affected303 at risk
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG00022 events21 affected301 at risk EG00126 events23 affected303 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG00062 events60 affected301 at risk EG00165 events60 affected303 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG00062 events54 affected301 at risk EG00162 events54 affected303 at risk
Fatigue	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG00040 events39 affected301 at risk EG00143 events40 affected303 at risk
Chest pain	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG00037 events36 affected301 at risk EG00154 events52 affected303 at risk
Pyrexia	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG00025 events23 affected301 at risk EG00134 events30 affected303 at risk

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	SNG001	Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
BG001	Placebo	Patients received Placebo via inhalation using nebuliser, once a day for 14 days
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SNG001	Patients received SNG001 via inhalation using Ultra nebuliser, once a day for 14 days	16	309	38	301	250	301
EG001	Placebo	Patients received Placebo via inhalation using Ultra nebuliser, once a day for 14 days	18	314	55	303	248	303