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Trial record 2 of 3 for:    synairgen | Covid19

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

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ClinicalTrials.gov Identifier: NCT04732949
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Synairgen Research Ltd.

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.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Drug: SNG001 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SNG001
SNG001 via inhalation using Ultra device, once a day for 14 days
Drug: SNG001
SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day

Placebo Comparator: Placebo
Placebo via inhalation using Ultra device, once a day for 14 days
Drug: Placebo
Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution




Primary Outcome Measures :
  1. Time to hospital discharge [ Time Frame: Day 1 until Day 28 ]
    To evaluate the time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo. Here, hospital discharge can be considered when World Health Organization (WHO) Ordinal Scale for Clinical Improvement (OSCI) score of 2 (limitation of activities) or below, with no rebound at subsequent assessments. 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.

  2. Time to recovery [ Time Frame: Day 1 until Day 28 ]
    To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery. Here, recovery is defined as the WHO OSCI score of 1 (no limitation of activities) or below, with no rebound at subsequent assessments. 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.


Secondary Outcome Measures :
  1. Progression to severe disease or death [ Time Frame: Day 1 until Day 35 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death. Progression to severe disease or death is defined by the WHO OSCI score of 5 (non-invasive ventilation or high-flow oxygen) or above within 35 days of first dose. 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. This is a key secondary endpoint.

  2. Progression to intubation or death [ Time Frame: Day 1 until Day 35 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death. Here, progression to intubation or death defined by the WHO OSCI score of 6 (intubation and mechanical ventilation) or above within 35 days of first dose. 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. This is a key secondary endpoint.

  3. Death within 35 days of first dose [ Time Frame: Day 1 until Day 35 ]
    Death within 35 days of first dose, defined by the WHO OSCI score of 8 (death). This is a key secondary endpoint.

  4. Recovery as analysed at Days 7, 14, 21 and 28 [ Time Frame: Days 7, 14, 21 and 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery. Recovery is defined as the WHO OSCI score of 1 (no limitation of activities) or below, with no rebound at subsequent assessments. 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.

  5. Hospital discharge at days 7, 14, 21 and 28 [ Time Frame: Days 7, 14, 21 and 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing hospital discharge on given days.

  6. Number of patients with improvement based on entire WHO OSCI score at days 7, 14, 21 and 28 [ Time Frame: Days 7, 14, 21 and 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI. 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.

  7. Change in total score according to the breathlessness, cough and sputum scale (BCSS) and disaggregated breathlessness and cough scores [ Time Frame: Day 1 until Day 28 and then on Day 60 and Day 90 ]
    To evaluate 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)

  8. Changes in National Early Warning Score (NEWS2) during the hospitalisation period [ Time Frame: Day 1 until Day 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period. The NEWS2 is a tool which is used in detection and response to clinical deterioration in adult patients and is a key element of patient safety and improving patient outcomes. Six physiological parameters such as: respiration rate, oxygen saturation, any supplementary oxygen, temperature, systolic blood pressure, heart rate, and alert, voice, pain, and unresponsive form the basis of the scoring system.

  9. Number of patients with presence of COVID-19 symptoms based on daily assessment [ Time Frame: Day 1 until Day 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of COVID-19 symptoms. The presence of COVID-19 symptoms will be assessed. Individual symptoms related to COVID-19/SARS-CoV-2 infection such as fever, breathlessness, and fatigue will be assessed.

  10. Number of patients with limitations of usual activities based on daily assessment [ Time Frame: Day 1 until Day 28 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of limitation of usual activities. The patients with limitations of usual activities will be patients who are unable to do usual activities (work, study, housework, family or leisure activities).

  11. Quality of life measured using EuroQol 5-dimension 5-level (EQ-5D-5L) [ Time Frame: Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90; Day 1 until Day 35 (mobility, self care and usual activities dimension) ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by using EQ-5D-5L. The EQ-5D-5L provides a simple descriptive profile and a single index value for health status. The EQ-5D-5L self-rated questionnaire includes a visual analogue scale, which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life. It also includes the EQ-5D-5L descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Here, 100 means the best health and 0 means the worst health. The mobility, self-care and usual activities dimensions of the questionnaire will be assessed daily from Day 1 to Day 35.

  12. Number of patients with long-COVID-19 symptoms based on General Anxiety Disorder 7 Questionnaire (GAD-7) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms. Assessment of long-COVID-19 symptoms based on GAD-7. Scoring will be done based on how often patients have been bothered by the problems as: feeling nervous, anxious or on edge; not being able to stop or control worrying; worrying too much about different things; trouble relaxing; being so restless that it's hard to sit still; becoming easily annoyed or irritable, and feeling afraid at if something awful might happen. The scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates nearly bothered every day by any of the above problems. Higher scores indicated worse outcome.

  13. Number of patients with long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]
    Assessment of long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4). The FACIT Fatigue Scale (Version 4) will include 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 will be 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. Higher scores indicated worse outcome.

  14. Number of patients with long-COVID-19 symptoms based on Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]
    Assessment of long-COVID-19 symptoms based on PHQ-9. Patient health questionnaire included: little interest or pleasure in doing things; feeling down, depressed, or hopeless; trouble falling asleep or staying asleep, or sleeping too much; feeling tired or having little energy; poor appetite or overeating; feeling bad about yourself - or that you are a failure of have let yourself or your family down; trouble concentrating on things, such as reading the newspaper or watching television; moving or speaking so slowly that other people could have noticed or so fidgety or restless that you have been moving a lot more than usual; and thoughts that you would be better off dead; or thoughts of hurting yourself in some way. Based on responses on questionnaire, scoring will be done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates nearly bothered every day by any of the above problems. Higher scores indicated worse outcome.

  15. Number of patients with long-COVID-19 symptoms based on Brief Pain Inventory (Short Form) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]
    Assessment of long-COVID-19 symptoms based on brief pain inventory form. Form include questionnaires as: did patient had pain other than everyday kinds of pain on assessment day; body part where patient feels pain; rate patient's pain: at worst, at least in the last 24 hours, at average, and at right now, by giving scores from 0 to 10, where 0 indicates no pain and 10 represents pain as bad as one can imagine; treatments or medications receiving for pain by patients; rate how much relief have pain treatments have provided from 0% to 100%, where 0% represents no relief and 100% indicates complete relief; assessment of interference of pain in following patients activity: general activity; mood; walking ability; normal work; relations with other people; sleep; enjoyment of life, and assessment will be done by scoring and scores ranges from 0 to 10, where 0 represents pain does not interfere and 10 indicates pain completely interferes in above activity.

  16. Number of patients with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day 1 until Day 28 ]
    To assess 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to hospital due to the severity of their COVID-19
  • Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
  • Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
  • Provided informed consent
  • Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
  • Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy
  • Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.

Exclusion Criteria:

  • Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
  • Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
  • Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care
  • Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
  • Any condition, including findings in the patients' medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation
  • Participation in previous clinical trials of SNG001
  • Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study
  • Inability to use a nebuliser with a mouthpiece
  • Inability to comply with the requirements for storage conditions of study medication in the home setting
  • History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation
  • Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732949


Contacts
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Contact: Jody Brookes 44 (0) 23 8051 2800 Jody.Brookes@synairgen.com
Contact: Sophie Hemmings 44 (0) 23 8051 2800 Sophie.Hemmings@synairgen.com

Locations
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Sponsors and Collaborators
Synairgen Research Ltd.
Investigators
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Principal Investigator: Professor Tom Wilkinson University Hospital Southampton NHS Foundation Trust
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Responsible Party: Synairgen Research Ltd.
ClinicalTrials.gov Identifier: NCT04732949    
Other Study ID Numbers: SG018
2020-004743-83 ( EudraCT Number )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Synairgen Research Ltd.:
Coronavirus disease-2019 (COVID-19)
Interferon beta
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases