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CompletedNCT04732949SPRINTERUpdated Mar 27, 2023Results posted

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

A Phase 3 interventional study of SNG001 and Placebo in Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19, sponsored by Synairgen Research Ltd.. Completed at 112 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Synairgen Research Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
623
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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-CoV-2). Safety and other efficacy endpoints will also be assessed.

Read the 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 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.

02

Conditions studied

  • Severe Acute Respiratory Syndrome Coronavirus 2
  • COVID-19

Keywords

  • Coronavirus disease-2019 (COVID-19)
  • Interferon beta
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 623 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Synairgen Research Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
623 participants (actual)

Study arms

  • Active comparator
    SNG001

    SNG001 via inhalation using Ultra device, once a day for 14 days

    Drug: SNG001

  • Placebo comparator
    Placebo

    Placebo via inhalation using Ultra device, once a day for 14 days

    Drug: Placebo

Interventions

  • DrugSNG001

    SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day

  • DrugPlacebo

    Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution

06

What researchers measure

Primary outcomes

  1. Time to Hospital Discharge

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

    Time frame: Day 28

  2. Time to Recovery

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

    Time frame: Day 28

Secondary outcomes

  1. 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.

    Time frame: Until Day 35

  2. 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.

    Time frame: Until Day 35

  3. 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.

    Time frame: Until Day 35 of first dose

  4. 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.

    Time frame: Days 7, 14, 21 and 28

  5. 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.

    Time frame: Days 7, 14, 21 and 28

  6. 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.

    Time frame: Until Day 35

  7. 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.

    Time frame: Baseline to Day 15

  8. 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.

    Time frame: Day 1 until Day 28

  9. 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.

    Time frame: Day 1 until Day 90

  10. 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).

    Time frame: Day 1 until Day 35

  11. 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.

    Time frame: Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90

  12. 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.

    Time frame: Day 15, Day 28, Day 60 and Day 90

  13. 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.

    Time frame: Day 15, Day 28, Day 60 and Day 90

  14. 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.

    Time frame: Day 15, Day 28, Day 60 and Day 90

  15. 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".

    Time frame: Day 15, Day 28, Day 60 and Day 90

  16. 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.

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

07

Results

Posted Mar 27, 2023

Participant flow

This trial was conducted at 112 centers which included 623 patients across 17 countries. The trial began on 12 January 2021 (first patient consented) and was completed on 10 Feb 2022.

Participant flow — Overall Study
MilestoneSNG001Placebo
Started309314
Completed233231
Not completed7683
Withdrew: Withdrawal by subject2327
Withdrew: Protocol violation01
Withdrew: Non-compliance02
Withdrew: Physician decision21
Withdrew: Serious adverse event (fatal)1618
Withdrew: Serious adverse event (non fatal)21
Withdrew: Non-serious adverse event13
Withdrew: Lost to follow-up2627
Withdrew: Other63

Outcome measures

PrimaryTime to Hospital Discharge

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

Time frame:
Day 28
Reported as:
Median · days
Time to Hospital Discharge
daysSNG001Placebo
Time to Hospital Discharge7.0 (7.0 to 8.0)8.0 (7.0 to 9.0)
Statistical analysis
  • SNG001 vs Placebo · Cox proportional hazard model · p = 0.509 · Hazard ratio (hr): 1.06 · 95% CI 0.89 to 1.27
PrimaryTime to Recovery

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

Time frame:
Day 28
Reported as:
Median · days
Time to Recovery
daysSNG001Placebo
Time to Recovery25.0 (22.0 to NA)25.0 (22.0 to NA)
Statistical analysis
  • SNG001 vs Placebo · Cox proportional hazard model · p = 0.888 · Hazard ratio (hr): 1.02 · 95% CI 0.81 to 1.28
SecondaryNumber 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.

Time frame:
Until Day 35
Reported as:
Count of participants · Participants
Number of Patients Who Progressed to Severe Disease or Death
ParticipantsSNG001Placebo
Number of Patients Who Progressed to Severe Disease or Death3345
Statistical analysis
  • SNG001 vs Placebo · Regression, Logistic · p = 0.161 · Odds ratio (or): 0.71 · 95% CI 0.44 to 1.15
SecondaryNumber 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.

Time frame:
Until Day 35
Reported as:
Count of participants · Participants
Number of Patients Who Were Intubated or Who Died
ParticipantsSNG001Placebo
Number of Patients Who Were Intubated or Who Died2023
Statistical analysis
  • SNG001 vs Placebo · Regression, Logistic · p = 0.610 · Odds ratio (or): 0.85 · 95% CI 0.45 to 1.61
SecondaryNumber of Patients Who Died Within 35 Days of First Dose

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

Time frame:
Until Day 35 of first dose
Reported as:
Count of participants · Participants
Number of Patients Who Died Within 35 Days of First Dose
ParticipantsSNG001Placebo
Number of Patients Who Died Within 35 Days of First Dose1417
Statistical analysis
  • SNG001 vs Placebo · Regression, Logistic · p = 0.544 · Odds ratio (or): 0.79 · 95% CI 0.38 to 1.67
SecondaryCumulative 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.

Time frame:
Days 7, 14, 21 and 28
Reported as:
Count of participants · Participants
Cumulative Number of Patients Who Were Discharged From Hospital
ParticipantsSNG001Placebo
Day 7154141
Day 14231223
Day 21245249
Day 28249255
Statistical analysis
  • SNG001 vs Placebo · Regression, Logistic · p = 0.323 · Odds ratio (or): 1.18 · 95% CI 0.85 to 1.64
  • SNG001 vs Placebo · Regression, Logistic · p = 0.406 · Odds ratio (or): 1.17 · 95% CI 0.81 to 1.70
  • SNG001 vs Placebo · Regression, Logistic · p = 0.828 · Odds ratio (or): 0.96 · 95% CI 0.64 to 1.43
  • SNG001 vs Placebo · Regression, Logistic · p = 0.706 · Odds ratio (or): 0.92 · 95% CI 0.61 to 1.40
SecondaryCumulative 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.

Time frame:
Days 7, 14, 21 and 28
Reported as:
Count of participants · Participants
Cumulative Number of Patients With Recovery
ParticipantsSNG001Placebo
Day 72817
Day 147573
Day 21117118
Day 28145151
Statistical analysis
  • SNG001 vs Placebo · Regression, Logistic · p = 0.101 · Odds ratio (or): 1.71 · 95% CI 0.90 to 3.22
  • SNG001 vs Placebo · Regression, Logistic · p = 0.942 · Odds ratio (or): 0.99 · 95% CI 0.67 to 1.45
  • SNG001 vs Placebo · Regression, Logistic · p = 0.824 · Odds ratio (or): 0.96 · 95% CI 0.68 to 1.35
  • SNG001 vs Placebo · Regression, Logistic · p = 0.613 · Odds ratio (or): 0.92 · 95% CI 0.66 to 1.28
SecondaryImprovement 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.

Time frame:
Until Day 35
Reported as:
Count of participants · Participants
Improvement Based on Entire WHO OSCI Score
ParticipantsSNG001Placebo
Baseline — 0 = No clinical or virological evidence of infection00
Baseline — 1 = No limitations of activities00
Baseline — 2 = Limitation of activities10
Baseline — 3 = Hospitalised - no oxygen therapy38
Baseline — 4 = Oxygen by mask, or nasal prongs304304
Baseline — 5 = Non-invasive ventilation, or high flow oxygen12
Baseline — 6 = Intubation and mechanical ventilation00
Baseline — 7 = Ventilation plus additional organ support00
Baseline — 8 = Death00
Baseline — Missing00
Day 7 — 0 = No clinical or virological evidence of infection2014
Day 7 — 1 = No limitations of activities1812
Day 7 — 2 = Limitation of activities115114
Day 7 — 3 = Hospitalised - no oxygen therapy4242
Day 7 — 4 = Oxygen by mask, or nasal prongs5369
Day 7 — 5 = Non-invasive ventilation, or high flow oxygen1826
Day 7 — 6 = Intubation and mechanical ventilation22
Day 7 — 7 = Ventilation plus additional organ support33
Day 7 — 8 = Death40
Day 7 — Missing3432
Day 14 — 0 = No clinical or virological evidence of infection6257
Day 14 — 1 = No limitations of activities2430
Day 14 — 2 = Limitation of activities135127
Day 14 — 3 = Hospitalised - no oxygen therapy1118
Day 14 — 4 = Oxygen by mask, or nasal prongs1315
Day 14 — 5 = Non-invasive ventilation, or high flow oxygen24
Day 14 — 6 = Intubation and mechanical ventilation31
Day 14 — 7 = Ventilation plus additional organ support39
Day 14 — 8 = Death97
Day 14 — Missing4746
Day 21 — 0 = No clinical or virological evidence of infection8994
Day 21 — 1 = No limitations of activities3223
Day 21 — 2 = Limitation of activities109114
Day 21 — 3 = Hospitalised - no oxygen therapy34
Day 21 — 4 = Oxygen by mask, or nasal prongs74
Day 21 — 5 = Non-invasive ventilation, or high flow oxygen10
Day 21 — 6 = Intubation and mechanical ventilation21
Day 21 — 7 = Ventilation plus additional organ support28
Day 21 — 8 = Death129
Day 21 — Missing5257
Day 28 — 0 = No clinical or virological evidence of infection123134
Day 28 — 1 = No limitations of activities2313
Day 28 — 2 = Limitation of activities8595
Day 28 — 3 = Hospitalised - no oxygen therapy00
Day 28 — 4 = Oxygen by mask, or nasal prongs32
Day 28 — 5 = Non-invasive ventilation, or high flow oxygen40
Day 28 — 6 = Intubation and mechanical ventilation01
Day 28 — 7 = Ventilation plus additional organ support13
Day 28 — 8 = Death1414
Day 28 — Missing5652
Day 35 — 0 = No clinical or virological evidence of infection147153
Day 35 — 1 = No limitations of activities1016
Day 35 — 2 = Limitation of activities7173
Day 35 — 3 = Hospitalised - no oxygen therapy00
Day 35 — 4 = Oxygen by mask, or nasal prongs21
Day 35 — 5 = Non-invasive ventilation, or high flow oxygen10
Day 35 — 6 = Intubation and mechanical ventilation21
Day 35 — 7 = Ventilation plus additional organ support11
Day 35 — 8 = Death1417
Day 35 — Missing6152
SecondaryChange 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.

Time frame:
Baseline to Day 15
Reported as:
Least squares mean · score on a scale
Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)
score on a scaleSNG001Placebo
Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)-2.1 ± 0.09-2.2 ± 0.09
Statistical analysis
  • SNG001 vs Placebo · Mixed Models Analysis · p = 0.410 · Mean difference (final values): 0.1 · 95% CI -0.1 to 0.3
SecondaryChange 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.

Time frame:
Day 1 until Day 28
Reported as:
Mean · score on a scale
Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period
score on a scaleSNG001Placebo
Day 7-0.7 ± 3.08-0.7 ± 2.55
Day 140.2 ± 3.83-0.3 ± 3.32
Day 212.8 ± 3.162.3 ± 3.62
Day 28-0.5 ± 2.084.5 ± 4.37
SecondaryNumber 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.

Time frame:
Day 1 until Day 90
Reported as:
Count of participants · Participants
Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment
ParticipantsSNG001Placebo
Baseline306310
Day 7221234
Day 14169162
Day 21154139
Day 28122117
Day 356169
Day 604457
Day 904151
SecondaryNumber 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).

Time frame:
Day 1 until Day 35
Reported as:
Count of participants · Participants
Number of Patients With Limitations of Usual Activities Based on Daily Assessment
ParticipantsSNG001Placebo
Day 101
Day 7115114
Day 14135127
Day 21109114
Day 288595
Day 357173
SecondaryQuality 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.

Time frame:
Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90
Reported as:
Mean · score on a scale
Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)
score on a scaleSNG001Placebo
Day 056.4 ± 21.7256.9 ± 20.95
Day 772.6 ± 18.3971.1 ± 20.44
Day 1579.5 ± 18.2579.0 ± 16.51
Day 2883.3 ± 16.0083.5 ± 14.90
Day 6088.9 ± 14.1688.0 ± 13.56
Day 9090.3 ± 12.6589.9 ± 13.65
SecondaryGeneral 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.

Time frame:
Day 15, Day 28, Day 60 and Day 90
Reported as:
Mean · score on a scale
General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score
score on a scaleSNG001Placebo
Day 153.3 ± 4.083.5 ± 4.30
Day 282.2 ± 3.671.9 ± 3.29
Day 601.4 ± 3.061.7 ± 3.38
Day 901.0 ± 2.411.6 ± 3.43
SecondaryFunctional 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.

Time frame:
Day 15, Day 28, Day 60 and Day 90
Reported as:
Mean · score on a scale
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score
score on a scaleSNG001Placebo
Day 1539.1 ± 9.7938.7 ± 10.31
Day 2842.5 ± 10.1942.8 ± 8.98
Day 6046.4 ± 8.2245.5 ± 7.96
Day 9046.9 ± 8.0146.3 ± 7.78
SecondaryPatient 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.

Time frame:
Day 15, Day 28, Day 60 and Day 90
Reported as:
Mean · score on a scale
Patient Health Questionnaire-9 (PHQ-9) Total Score
score on a scaleSNG001Placebo
Day 154.6 ± 4.475.0 ± 4.71
Day 283.2 ± 4.153.1 ± 4.02
Day 601.7 ± 3.232.1 ± 3.85
Day 901.5 ± 3.052.0 ± 3.89
SecondaryOverall 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".

Time frame:
Day 15, Day 28, Day 60 and Day 90
Reported as:
Mean · score on a scale
Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores
score on a scaleSNG001Placebo
Day 153.4 ± 2.133.3 ± 1.98
Day 283.2 ± 1.983.2 ± 1.77
Day 604.1 ± 1.543.3 ± 1.94
Day 904.5 ± 2.143.5 ± 2.33
SecondaryNumber 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.

Time frame:
From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
Reported as:
Count of participants · Participants
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsSNG001Placebo
Any Treatment-emergent adverse event (TEAE)251251
Any serious TEAE3855
Any serious related TEAE33
Any fatal TEAE1616
Any fatal TEAE related to study treatment00
Any TEAE related to study treatment6877
Any TEAE leading to discontinuation of study treatment2423
Any Adverse Events of Note01

Adverse events

Collected over From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SNG00116/309 (5.2%)38/301 (12.6%)250/301 (83.1%)
Placebo18/314 (5.7%)55/303 (18.2%)248/303 (81.8%)
Most frequent serious events
Showing 10 of 50
Most frequent serious events
EventSNG001Placebo
COVID-19Infections and infestations11/3018/303
Respiratory failureRespiratory, thoracic and mediastinal disorders9/3019/303
COVID-19 pneumoniaInfections and infestations8/3018/303
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/3017/303
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/3015/303
PneumoniaInfections and infestations3/3010/303
Acute kidney injuryRenal and urinary disorders3/3012/303
Acute myocardial infarctionCardiac disorders2/3011/303
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders2/3011/303
Cardiac arrestCardiac disorders1/3012/303
Most frequent other events
Showing 10 of 19
Most frequent other events
EventSNG001Placebo
Productive coughRespiratory, thoracic and mediastinal disorders70/30172/303
HeadacheNervous system disorders71/30161/303
MyalgiaMusculoskeletal and connective tissue disorders60/30160/303
RhinorrhoeaRespiratory, thoracic and mediastinal disorders58/30154/303
Oropharyngeal painRespiratory, thoracic and mediastinal disorders55/30147/303
ArthralgiaMusculoskeletal and connective tissue disorders54/30154/303
Chest painGeneral disorders36/30152/303
WheezingRespiratory, thoracic and mediastinal disorders45/30135/303
DyspnoeaRespiratory, thoracic and mediastinal disorders30/30141/303
FatigueGeneral disorders39/30140/303

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)SNG001PlaceboTotal
Mean52 ± 15.1953.7 ± 14.4252.8 ± 14.82
Sex: Female, Male
Sex: Female, Male(Participants)SNG001PlaceboTotal
Female203208411
Male106106212
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SNG001PlaceboTotal
Hispanic or Latino5349102
Not Hispanic or Latino238242480
Unknown or Not Reported182341
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SNG001PlaceboTotal
White224215439
Black7613
Asian- Chinese224
Asian- Other404686
Arab257
American Indian5510
Other101323
Unknown192241
08

Study locations

112 sites
  • The University of Arizona Medi
    Tucson, Arizona 85724, United States
  • Professional Health Care of Pi
    Saint Petersburg, Florida 33713, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Icahn School of Medicine at Mo
    New York, New York 10029-6500, United States
  • PharmaTex Research, LLC
    Amarillo, Texas 79109, United States
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
    Ciudad Autónoma De Buenos Air, Buenos Aires C1426BOR, Argentina
  • Hospital Universitario Austral
    Buenos Aires, B1629ODT, Argentina
  • Hospital Papa Francisco - Hosp
    Salta, 4400, Argentina
  • AZ Groeninge
    Kortrijk, West-Vlaanderen 8500, Belgium
  • UZ Brussel - Campus Jette - In
    Brussel, 1090, Belgium
  • Centre Hospitalier Universitai
    Bruxelles, 1020, Belgium
  • CHR de la Citadelle - Site Cit
    Liège, 4000, Belgium
  • CHU de Liège - Domaine Univers
    Liège, 4000, Belgium
  • Instituto Mederi de Pesquisa e Saúde
    Passo Fundo, Rio Grande Do Sul 99010-120, Brazil
  • Hospital Moinhos de Vento
    Porto Alegre, Rio Grande Do Sul 90035-001, Brazil
  • Clínica SUPERA
    Chapeco, Santa Catarina 89801-355, Brazil
  • Sociedade Literaria e Caritativa Santo Agostinho
    Criciúma, Santa Catarina 88801-508, Brazil
  • Instituto de Pesquisa Clínica
    Campinas, São Paulo 13060-080, Brazil
  • Fundacao Faculdade Regional de
    São José do Rio Preto, São Paulo 15090-000, Brazil
  • Clinica de la Mujer
    Bogotá, Cundinamarca, Colombia
  • FOSCAL
    Bucaramanga, Santander 681004, Colombia
  • Clinica de la Costa
    Barranquilla, Colombia
  • CHU De Nantes - Infectious Dis
    Nantes, Loire-Atlantique 44093, France
  • CHU d'Angers
    Angers, Pays-de-la-Loire 49933, France
  • CHU de Grenoble - Hôpital Albe
    La Tronche, 38700, France
  • CHU Saint Antoine - Infectious
    Paris, 75012, France
  • Hôpital Européen Georges-Pompi
    Paris, 75015, France
  • Hopital Bichat - Infectious Di
    Paris, 75018, France
  • RoMed Medical Center Rosenheim
    Rosenheim, Bayern 83022, Germany
  • Universitätsklinikum Mannheim
    Mannheim, 68167, Germany
  • Krankenhaus Bethanien gGmbH
    Solingen, 42699, Germany
  • King George Hospital
    Visakhapatnam, Andhra Pradesh 530002, India
  • Unity Hospital
    Surat, Gujarat 395010, India
  • Rhythm Heart Institute
    Vadodara, Gujarat 390022, India
  • Bangalore Medical College and Research Institute
    Bangalore, Karnataka 560002, India
  • MS Ramaiah Medical College and Hospital
    Bangalore, Karnataka 560054, India
  • Oriion Citicare Super Speciality Hospital - Intern
    Aurangabad, Maharashtra 431005, India
  • Fortis Hospital Mulund - Inter
    Mumbai, Maharashtra 400078, India
  • Government Medical College Nag
    Nagpur, Maharashtra 440003, India
  • Suyog Hospital
    Nashik, Maharashtra 422003, India
  • Vishwa Raj Hospital
    Pune, Maharashtra 412201, India
  • Acharya Vinoba Bhave Rural Hos
    Wardha, Maharashtra 442004, India
  • Post Graduate Institute of Medical Education & Research, Chandigarh
    Chandigarh, Punjab 160012, India
  • Saveetha Medical College & Hospital
    Chennai, 602105, India
  • Assuta Ashdod University Hospi
    Ashdod, HaDarom 7747629, Israel
  • Rambam Health Care Campus
    Haifa, 3109601, Israel
  • Ziv Medical Center
    Safed, 131001, Israel
  • The Chaim Sheba Medical Center
    Tel Hashomer, 5265601, Israel
  • Sourasky Tel Aviv Medical Cent
    Tel-Aviv, 6423906, Israel
  • Assaf Harofeh Medical Center
    Zerifin, 7030000, Israel
  • Azienda Socio Sanitaria Territ
    Monza, Lombardia 20900, Italy
  • Azienda Ospedaliera Nazionale
    Alessandria, 15100, Italy
  • PO A.Manzoni di Lecco, ASST Le
    Lecco, 23900, Italy
  • Ospedale Luigi Sacco, AO-PU
    Milano, 20157, Italy
  • Azienda Ospedaliera Ospedale N
    Milano, 20162, Italy
  • AOU Federico II - Malattie Inf
    Napoli, 80131, Italy
  • IRCCS Policlinico San Matteo
    Pavia, 27100, Italy
  • AOU Pisana
    Pisa, 54124, Italy
  • Città della Salute e della Scienza
    Torino, 10139, Italy
  • Fundación Santos y de la Garza Evia, I.B.P
    Monterrey, Nuevo León 64710, Mexico
  • Hospital General de Culiacan D
    Culiacan, Sinaloa 80230, Mexico
  • EME RED Hospitalaria - COVID-1
    Merida, Yucatán 97000, Mexico
  • Hospital General Regional O´Hu
    Merida, Yucatán 97000, Mexico
  • Clínica Sociedad Española de Beneficencia
    Veracruz, 91700, Mexico
  • Ziekenhuis St Jansdal
    Harderwijk, Gelderland 3844 DG, Netherlands
  • Gelre Ziekenhuis Zutphen
    Zutphen, Gelderland 7207 AE, Netherlands
  • Isala Klinieken
    Zwolle, Overijssel 8025 AB, Netherlands
  • Hospital Garcia da Orta, E.P.E
    Almada, Lisboa 2805-267, Portugal
  • C.H. de Vila Nova de Gaia/Espi
    Vila Nova de Gaia, Porto 4434-502, Portugal
  • Hospital de Braga
    Braga, 4710-243, Portugal
  • Hospital da Senhora de Oliveir
    Guimarães, 4835-044, Portugal
  • Centro Hospitalar de Entre Dou
    Rodrigues, 4520-211, Portugal
  • Sp. Clinic Boli Infectioase si
    Timisoara, Timis 300310, Romania
  • Spitalul Universitar de Urgent
    Bucuresti, 011461, Romania
  • Sp. Cl. de Boli Infectioase si
    Bucuresti, 030303, Romania
  • Spitalul Clinic de Boli Infect
    Craiova, 200446, Romania
  • Clinical Center Nis
    Nis, Nišavski Okrug 18000, Serbia
  • Clinical Center of Vojvodina
    Novi Sad, Vojvodina 21000, Serbia
  • University Clinical Center of Serbia
    Belgrade, 11000, Serbia
  • Clinical Center Kragujevac, Cl
    Kragujevac, 34000, Serbia
  • The Institute for Pulmonary Di
    Sremska Kamenica, 21204, Serbia
  • CHU A Coruña
    Madrid, A Coruña 15006, Spain
  • Hospital Universitario Son Esp
    Palma De Mallorca, Baleares 7120, Spain
  • Hospital Universitario Mutua d
    Terrassa, Barcelona 08221, Spain
  • Hospital Universitario de Puer
    Puerto Real, Cádiz 11510, Spain
  • Hospital Santa Creu i Sant Pau
    Barcelona, 08041, Spain
  • Hospital Universitario Infanta
    Madrid, 28031, Spain
  • Hospital Universitario Ramón y
    Madrid, 28034, Spain
  • H.Clinico San Carlos
    Madrid, 28040, Spain
  • Hospital Universitario de Sala
    Salamanca, 37007, Spain
  • H U Nuesta Señora de Valme - I
    Sevilla, Spain
  • Wexham Park Hospital
    Slough, Bracknell Forest SL2 4HL, United Kingdom
  • Hull Royal Infirmary
    Hull, North Humberside, East Riding Of Yorkshire HU3 2RW, United Kingdom
  • Newcastle University - Institute of Cellular Medicine (ICM)
    Newcastle, England NE2 4HH, United Kingdom
  • Southampton General Hospital
    Southampton, Hampshire SO16 6YD, United Kingdom
  • Churchill Hospital
    Headington, Oxfordshire OX3 9DU, United Kingdom
  • Frimley Park Hospital
    Frimley, Surrey GU16 7UJ, United Kingdom
  • Queen Elizabeth Hospital Birmingham
    Birmingham, B15 2TH, United Kingdom
  • The Royal Bournemouth & Christ
    Bournemouth, BH7 7DP, United Kingdom

Showing the first 100 of 112 sites across 17 countries.

09

References and documents

Study documents

  • Study protocol · Sep 9, 2021
  • Statistical analysis plan · Feb 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04732949
Lead sponsor
Synairgen Research Ltd.
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Jan 12, 2021
Primary completion
Dec 15, 2021
Completion
Feb 10, 2022
Results posted
Mar 27, 2023
Last update
Mar 27, 2023

Study contacts

Professor Tom Wilkinson
principal investigator · University Hospital Southampton NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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