Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
Conditions
Keywords
Coronavirus disease-2019 (COVID-19), Interferon beta
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-CoV-2). Safety and other efficacy endpoints will also be assessed.
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.
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
Sponsors
Synairgen Research Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Discharge | Day 28 | The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated. |
| Time to Recovery | Day 28 | Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Died Within 35 Days of First Dose | Until Day 35 of first dose | Patients who died within 35 days of first dose of study intervention were calculated. |
| Cumulative Number of Patients Who Were Discharged From Hospital | Days 7, 14, 21 and 28 | The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 was assessed by hospital discharge on given days. |
| Cumulative Number of Patients With Recovery | Days 7, 14, 21 and 28 | 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. |
| Improvement Based on Entire WHO OSCI Score | Until Day 35 | 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. |
| Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS) | Baseline to Day 15 | 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. |
| Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 1 until Day 28 | 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. |
| Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 1 until Day 90 | 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. |
| Number of Patients Who Progressed to Severe Disease or Death | Until Day 35 | 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. |
| Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90 | 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. |
| General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 15, Day 28, Day 60 and Day 90 | 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. |
| Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 15, Day 28, Day 60 and Day 90 | 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. |
| Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 15, Day 28, Day 60 and Day 90 | 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. |
| Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 15, Day 28, Day 60 and Day 90 | 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. |
| Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90) | 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. |
| Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 1 until Day 35 | 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). |
| Number of Patients Who Were Intubated or Who Died | Until Day 35 | 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. |
Countries
Argentina, Belgium, Brazil, Colombia, France, Germany, India, Israel, Italy, Mexico, Netherlands, Portugal, Romania, Serbia, Spain, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
The pre-treatment assessments were performed on Day 0 prior to the first dose preferably. All the study assessments were performed as per the schedule of assessments.
Participants by arm
| Arm | Count |
|---|---|
| SNG001 Patients received SNG001 via inhalation using nebuliser, once a day for 14 days | 309 |
| Placebo Patients received Placebo via inhalation using nebuliser, once a day for 14 days | 314 |
| Total | 623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 27 |
| Overall Study | Non-compliance | 0 | 2 |
| Overall Study | Non-serious adverse event | 1 | 3 |
| Overall Study | Other | 6 | 3 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Serious adverse event (Fatal) | 16 | 18 |
| Overall Study | Serious adverse event (Non fatal) | 2 | 1 |
| Overall Study | Withdrawal by Subject | 23 | 27 |
Baseline characteristics
| Characteristic | Total | SNG001 | Placebo |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 14.82 | 52 years STANDARD_DEVIATION 15.19 | 53.7 years STANDARD_DEVIATION 14.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 102 Participants | 53 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 480 Participants | 238 Participants | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants | 18 Participants | 23 Participants |
| Race/Ethnicity, Customized American Indian | 10 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Arab | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian- Chinese | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian- Other | 86 Participants | 40 Participants | 46 Participants |
| Race/Ethnicity, Customized Black | 13 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 23 Participants | 10 Participants | 13 Participants |
| Race/Ethnicity, Customized Unknown | 41 Participants | 19 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 439 Participants | 224 Participants | 215 Participants |
| Sex: Female, Male Female | 411 Participants | 203 Participants | 208 Participants |
| Sex: Female, Male Male | 212 Participants | 106 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 309 | 18 / 314 |
| other Total, other adverse events | 250 / 301 | 248 / 303 |
| serious Total, serious adverse events | 38 / 301 | 55 / 303 |
Outcome results
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.
Time frame: Day 28
Population: The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNG001 | Time to Hospital Discharge | 7.0 days |
| Placebo | Time to Hospital Discharge | 8.0 days |
Comparison: Hazard Ratio for time to hospital discharge - SNG001 vs Placebop-value: 0.50995% CI: [0.89, 1.27]Cox proportional hazard model
Primary
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
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNG001 | Time to Recovery | 25.0 days |
| Placebo | Time to Recovery | 25.0 days |
Comparison: Hazard Ratio for time to OSCI recovery - SNG001 vs Placebop-value: 0.88895% CI: [0.81, 1.28]Cox proportional hazard model
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.
Time frame: Day 1 until Day 28
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 7 | -0.7 score on a scale | Standard Deviation 3.08 |
| SNG001 | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 14 | 0.2 score on a scale | Standard Deviation 3.83 |
| SNG001 | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 21 | 2.8 score on a scale | Standard Deviation 3.16 |
| SNG001 | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 28 | -0.5 score on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 28 | 4.5 score on a scale | Standard Deviation 4.37 |
| Placebo | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 7 | -0.7 score on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 21 | 2.3 score on a scale | Standard Deviation 3.62 |
| Placebo | Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period | Day 14 | -0.3 score on a scale | Standard Deviation 3.32 |
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.
Time frame: Baseline to Day 15
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SNG001 | Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS) | -2.1 score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS) | -2.2 score on a scale | Standard Error 0.09 |
Comparison: SNG001 vs Placebop-value: 0.4195% CI: [-0.1, 0.3]Mixed Models Analysis
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.
Time frame: Days 7, 14, 21 and 28
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNG001 | Cumulative Number of Patients Who Were Discharged From Hospital | Day 21 | 245 Participants |
| SNG001 | Cumulative Number of Patients Who Were Discharged From Hospital | Day 7 | 154 Participants |
| SNG001 | Cumulative Number of Patients Who Were Discharged From Hospital | Day 28 | 249 Participants |
| SNG001 | Cumulative Number of Patients Who Were Discharged From Hospital | Day 14 | 231 Participants |
| Placebo | Cumulative Number of Patients Who Were Discharged From Hospital | Day 28 | 255 Participants |
| Placebo | Cumulative Number of Patients Who Were Discharged From Hospital | Day 7 | 141 Participants |
| Placebo | Cumulative Number of Patients Who Were Discharged From Hospital | Day 21 | 249 Participants |
| Placebo | Cumulative Number of Patients Who Were Discharged From Hospital | Day 14 | 223 Participants |
Comparison: Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebop-value: 0.32395% CI: [0.85, 1.64]Regression, Logistic
Comparison: Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebop-value: 0.40695% CI: [0.81, 1.7]Regression, Logistic
Comparison: Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebop-value: 0.82895% CI: [0.64, 1.43]Regression, Logistic
Comparison: Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebop-value: 0.70695% CI: [0.61, 1.4]Regression, Logistic
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.
Time frame: Days 7, 14, 21 and 28
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNG001 | Cumulative Number of Patients With Recovery | Day 21 | 117 Participants |
| SNG001 | Cumulative Number of Patients With Recovery | Day 7 | 28 Participants |
| SNG001 | Cumulative Number of Patients With Recovery | Day 28 | 145 Participants |
| SNG001 | Cumulative Number of Patients With Recovery | Day 14 | 75 Participants |
| Placebo | Cumulative Number of Patients With Recovery | Day 28 | 151 Participants |
| Placebo | Cumulative Number of Patients With Recovery | Day 7 | 17 Participants |
| Placebo | Cumulative Number of Patients With Recovery | Day 21 | 118 Participants |
| Placebo | Cumulative Number of Patients With Recovery | Day 14 | 73 Participants |
Comparison: Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebop-value: 0.10195% CI: [0.9, 3.22]Regression, Logistic
Comparison: Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebop-value: 0.94295% CI: [0.67, 1.45]Regression, Logistic
Comparison: Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebop-value: 0.82495% CI: [0.68, 1.35]Regression, Logistic
Comparison: Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebop-value: 0.61395% CI: [0.66, 1.28]Regression, Logistic
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.
Time frame: Day 15, Day 28, Day 60 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 15 | 39.1 score on a scale | Standard Deviation 9.79 |
| SNG001 | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 28 | 42.5 score on a scale | Standard Deviation 10.19 |
| SNG001 | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 60 | 46.4 score on a scale | Standard Deviation 8.22 |
| SNG001 | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 90 | 46.9 score on a scale | Standard Deviation 8.01 |
| Placebo | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 90 | 46.3 score on a scale | Standard Deviation 7.78 |
| Placebo | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 15 | 38.7 score on a scale | Standard Deviation 10.31 |
| Placebo | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 60 | 45.5 score on a scale | Standard Deviation 7.96 |
| Placebo | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score | Day 28 | 42.8 score on a scale | Standard Deviation 8.98 |
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.
Time frame: Day 15, Day 28, Day 60 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 15 | 3.3 score on a scale | Standard Deviation 4.08 |
| SNG001 | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 28 | 2.2 score on a scale | Standard Deviation 3.67 |
| SNG001 | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 60 | 1.4 score on a scale | Standard Deviation 3.06 |
| SNG001 | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 90 | 1.0 score on a scale | Standard Deviation 2.41 |
| Placebo | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 90 | 1.6 score on a scale | Standard Deviation 3.43 |
| Placebo | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 15 | 3.5 score on a scale | Standard Deviation 4.3 |
| Placebo | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 60 | 1.7 score on a scale | Standard Deviation 3.38 |
| Placebo | General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score | Day 28 | 1.9 score on a scale | Standard Deviation 3.29 |
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.
Time frame: Until Day 35
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 0 = No clinical or virological evidence of infection | 89 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 8 = Death | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 1 = No limitations of activities | 32 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 6 = Intubation and mechanical ventilation | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 2 = Limitation of activities | 109 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 1 = No limitations of activities | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 3 = Hospitalised - no oxygen therapy | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 7 = Ventilation plus additional organ support | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 4 = Oxygen by mask, or nasal prongs | 7 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | Missing | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 5 = Non-invasive ventilation, or high flow oxygen | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 8 = Death | 4 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 6 = Intubation and mechanical ventilation | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 5 = Non-invasive ventilation, or high flow oxygen | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 7 = Ventilation plus additional organ support | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | Missing | 34 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | 8 = Death | 12 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 0 = No clinical or virological evidence of infection | 20 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 21 | Missing | 52 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 0 = No clinical or virological evidence of infection | 62 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 0 = No clinical or virological evidence of infection | 123 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 3 = Hospitalised - no oxygen therapy | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 1 = No limitations of activities | 23 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 1 = No limitations of activities | 24 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 2 = Limitation of activities | 85 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 1 = No limitations of activities | 18 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 3 = Hospitalised - no oxygen therapy | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 2 = Limitation of activities | 135 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 4 = Oxygen by mask, or nasal prongs | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 6 = Intubation and mechanical ventilation | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 5 = Non-invasive ventilation, or high flow oxygen | 4 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 3 = Hospitalised - no oxygen therapy | 11 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 6 = Intubation and mechanical ventilation | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 2 = Limitation of activities | 115 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 7 = Ventilation plus additional organ support | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 4 = Oxygen by mask, or nasal prongs | 13 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | 8 = Death | 14 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 2 = Limitation of activities | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 28 | Missing | 56 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 5 = Non-invasive ventilation, or high flow oxygen | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 0 = No clinical or virological evidence of infection | 147 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 3 = Hospitalised - no oxygen therapy | 42 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 1 = No limitations of activities | 10 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 6 = Intubation and mechanical ventilation | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 2 = Limitation of activities | 71 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 7 = Ventilation plus additional organ support | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 3 = Hospitalised - no oxygen therapy | 0 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 7 = Ventilation plus additional organ support | 3 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 4 = Oxygen by mask, or nasal prongs | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 4 = Oxygen by mask, or nasal prongs | 53 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 5 = Non-invasive ventilation, or high flow oxygen | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | 8 = Death | 9 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 6 = Intubation and mechanical ventilation | 2 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 4 = Oxygen by mask, or nasal prongs | 304 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 7 = Ventilation plus additional organ support | 1 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 14 | Missing | 47 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | 8 = Death | 14 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 7 | 5 = Non-invasive ventilation, or high flow oxygen | 18 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Day 35 | Missing | 61 Participants |
| SNG001 | Improvement Based on Entire WHO OSCI Score | Baseline | 0 = No clinical or virological evidence of infection | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | Missing | 52 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 0 = No clinical or virological evidence of infection | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 1 = No limitations of activities | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 2 = Limitation of activities | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 3 = Hospitalised - no oxygen therapy | 8 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 4 = Oxygen by mask, or nasal prongs | 304 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 5 = Non-invasive ventilation, or high flow oxygen | 2 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 6 = Intubation and mechanical ventilation | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 7 = Ventilation plus additional organ support | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | 8 = Death | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Baseline | Missing | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 0 = No clinical or virological evidence of infection | 14 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 1 = No limitations of activities | 12 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 2 = Limitation of activities | 114 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 3 = Hospitalised - no oxygen therapy | 42 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 4 = Oxygen by mask, or nasal prongs | 69 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 5 = Non-invasive ventilation, or high flow oxygen | 26 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 6 = Intubation and mechanical ventilation | 2 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 7 = Ventilation plus additional organ support | 3 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | 8 = Death | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 7 | Missing | 32 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 0 = No clinical or virological evidence of infection | 57 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 1 = No limitations of activities | 30 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 2 = Limitation of activities | 127 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 3 = Hospitalised - no oxygen therapy | 18 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 4 = Oxygen by mask, or nasal prongs | 15 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 5 = Non-invasive ventilation, or high flow oxygen | 4 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 6 = Intubation and mechanical ventilation | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 7 = Ventilation plus additional organ support | 9 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | 8 = Death | 7 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 14 | Missing | 46 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 0 = No clinical or virological evidence of infection | 94 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 1 = No limitations of activities | 23 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 2 = Limitation of activities | 114 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 3 = Hospitalised - no oxygen therapy | 4 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 4 = Oxygen by mask, or nasal prongs | 4 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 5 = Non-invasive ventilation, or high flow oxygen | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 6 = Intubation and mechanical ventilation | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 7 = Ventilation plus additional organ support | 8 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | 8 = Death | 9 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 21 | Missing | 57 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 0 = No clinical or virological evidence of infection | 134 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 1 = No limitations of activities | 13 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 2 = Limitation of activities | 95 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 3 = Hospitalised - no oxygen therapy | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 4 = Oxygen by mask, or nasal prongs | 2 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 5 = Non-invasive ventilation, or high flow oxygen | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 6 = Intubation and mechanical ventilation | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 7 = Ventilation plus additional organ support | 3 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | 8 = Death | 14 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 28 | Missing | 52 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 0 = No clinical or virological evidence of infection | 153 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 1 = No limitations of activities | 16 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 2 = Limitation of activities | 73 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 3 = Hospitalised - no oxygen therapy | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 4 = Oxygen by mask, or nasal prongs | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 5 = Non-invasive ventilation, or high flow oxygen | 0 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 6 = Intubation and mechanical ventilation | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 7 = Ventilation plus additional organ support | 1 Participants |
| Placebo | Improvement Based on Entire WHO OSCI Score | Day 35 | 8 = Death | 17 Participants |
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.
Time frame: Until Day 35 of first dose
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNG001 | Number of Patients Who Died Within 35 Days of First Dose | 14 Participants |
| Placebo | Number of Patients Who Died Within 35 Days of First Dose | 17 Participants |
Comparison: Odds Ratio for death - SNG001 vs Placebop-value: 0.54495% CI: [0.38, 1.67]Regression, Logistic
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.
Time frame: Until Day 35
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNG001 | Number of Patients Who Progressed to Severe Disease or Death | 33 Participants |
| Placebo | Number of Patients Who Progressed to Severe Disease or Death | 45 Participants |
Comparison: Odds Ratio for progression to severe disease or death - SNG001 vs Placebop-value: 0.16195% CI: [0.44, 1.15]Regression, Logistic
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.
Time frame: Until Day 35
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNG001 | Number of Patients Who Were Intubated or Who Died | 20 Participants |
| Placebo | Number of Patients Who Were Intubated or Who Died | 23 Participants |
Comparison: Odds Ratio for intubation or death - SNG001 vs Placebop-value: 0.6195% CI: [0.45, 1.61]Regression, Logistic
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.
Time frame: From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
Population: The Safety analysis population included all patients in the ITT population who receive at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any Treatment-emergent adverse event (TEAE) | 251 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAE | 38 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious related TEAE | 3 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fatal TEAE | 16 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fatal TEAE related to study treatment | 0 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE related to study treatment | 68 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to discontinuation of study treatment | 24 Participants |
| SNG001 | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any Adverse Events of Note | 0 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any Adverse Events of Note | 1 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any Treatment-emergent adverse event (TEAE) | 251 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fatal TEAE related to study treatment | 0 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAE | 55 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to discontinuation of study treatment | 23 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious related TEAE | 3 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE related to study treatment | 77 Participants |
| Placebo | Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fatal TEAE | 16 Participants |
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).
Time frame: Day 1 until Day 35
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 14 | 135 Participants |
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 1 | 0 Participants |
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 7 | 115 Participants |
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 21 | 109 Participants |
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 28 | 85 Participants |
| SNG001 | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 35 | 71 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 28 | 95 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 21 | 114 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 1 | 1 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 35 | 73 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 7 | 114 Participants |
| Placebo | Number of Patients With Limitations of Usual Activities Based on Daily Assessment | Day 14 | 127 Participants |
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.
Time frame: Day 1 until Day 90
Population: The ITT analysis population consisted of all randomised patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Baseline | 306 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 7 | 221 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 14 | 169 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 21 | 154 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 28 | 122 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 35 | 61 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 60 | 44 Participants |
| SNG001 | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 90 | 41 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 90 | 51 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Baseline | 310 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 28 | 117 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 7 | 234 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 60 | 57 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 14 | 162 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 35 | 69 Participants |
| Placebo | Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment | Day 21 | 139 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.
Time frame: Day 15, Day 28, Day 60 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 15 | 3.4 score on a scale | Standard Deviation 2.13 |
| SNG001 | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 28 | 3.2 score on a scale | Standard Deviation 1.98 |
| SNG001 | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 60 | 4.1 score on a scale | Standard Deviation 1.54 |
| SNG001 | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 90 | 4.5 score on a scale | Standard Deviation 2.14 |
| Placebo | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 90 | 3.5 score on a scale | Standard Deviation 2.33 |
| Placebo | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 15 | 3.3 score on a scale | Standard Deviation 1.98 |
| Placebo | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 60 | 3.3 score on a scale | Standard Deviation 1.94 |
| Placebo | Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores | Day 28 | 3.2 score on a scale | Standard Deviation 1.77 |
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.
Time frame: Day 15, Day 28, Day 60 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 15 | 4.6 score on a scale | Standard Deviation 4.47 |
| SNG001 | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 28 | 3.2 score on a scale | Standard Deviation 4.15 |
| SNG001 | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 60 | 1.7 score on a scale | Standard Deviation 3.23 |
| SNG001 | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 90 | 1.5 score on a scale | Standard Deviation 3.05 |
| Placebo | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 90 | 2.0 score on a scale | Standard Deviation 3.89 |
| Placebo | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 15 | 5.0 score on a scale | Standard Deviation 4.71 |
| Placebo | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 60 | 2.1 score on a scale | Standard Deviation 3.85 |
| Placebo | Patient Health Questionnaire-9 (PHQ-9) Total Score | Day 28 | 3.1 score on a scale | Standard Deviation 4.02 |
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.
Time frame: Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 0 | 56.4 score on a scale | Standard Deviation 21.72 |
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 7 | 72.6 score on a scale | Standard Deviation 18.39 |
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 15 | 79.5 score on a scale | Standard Deviation 18.25 |
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 28 | 83.3 score on a scale | Standard Deviation 16 |
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 60 | 88.9 score on a scale | Standard Deviation 14.16 |
| SNG001 | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 90 | 90.3 score on a scale | Standard Deviation 12.65 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 60 | 88.0 score on a scale | Standard Deviation 13.56 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 0 | 56.9 score on a scale | Standard Deviation 20.95 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 28 | 83.5 score on a scale | Standard Deviation 14.9 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 7 | 71.1 score on a scale | Standard Deviation 20.44 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 90 | 89.9 score on a scale | Standard Deviation 13.65 |
| Placebo | Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L) | Day 15 | 79.0 score on a scale | Standard Deviation 16.51 |