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Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection

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ClinicalTrials.gov Identifier: NCT04385095
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Synairgen Research Ltd.

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE March 16, 2020
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
Ordinal Scale for Clinical Improvement [ Time Frame: Day 1 to Days 15 and 28 ]
Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
Ordinal Scale for Clinical Improvement [ Time Frame: Day 1 to day 28 ]
Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • Progression to pneumonia (hospital setting only) [ Time Frame: Day 2 to Day 28 ]
    Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment
  • Progression to pneumonia (hospital setting only) [ Time Frame: Day 1 to Day 28 ]
    Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment
  • Time to clinical improvement (hospital setting only) [ Time Frame: Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hours ]
    Time to clinical improvement
  • National Early Warning Score 2 (NEWS2) assessment of acute-illness severity (hospital setting only) [ Time Frame: Day 1 to Day 28 ]
    NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)
  • Changes in daily breathlessness, cough and sputum scale (BCSS) [ Time Frame: Day 1 to Day 28 ]
    Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)
  • Safety and tolerability - blood pressure II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at blood pressure measured in mmHg
  • Safety and tolerability - heart rate II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at heart rate measured in beats per minute
  • Safety and tolerability - temperature II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at temperature measured in degrees Celsius
  • Safety and tolerability - respiratory rate II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at respiratory rate measure in breaths per minute
  • Safety and tolerability - oxygen saturation II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at oxygen levels measured in a %
  • Safety and tolerability - adverse events II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at adverse events (numbers and terms)
  • Safety and tolerability - concomitant medications II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at concomitant medications given during treatment
  • Time to clinical improvement (home setting only) [ Time Frame: Day 1 to Day 28 ]
    Temperature ≤37.8 °C AND COVID-19 symptoms (breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and taste, rhinorrhoea and anorexia) all rated as absent or mild
  • Time to improvement of COVID-19 symptoms (home setting only). [ Time Frame: Day 1 to Day 28 ]
    Time to improvement of COVID-19 symptoms (fever, breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and/or taste, rhinorrhoea and anorexia)
  • Time to self-reported recovery (home setting only) [ Time Frame: Day 2 to Day 16 ]
    Time to self-reported recover
  • Self-reported daily rating of overall feeling of wellness (home setting only). [ Time Frame: Day 1 to Day 28 ]
    Self-reported daily rating of overall feeling of wellness
  • Quality of life measured using EQ-5D-5L (home setting only). [ Time Frame: Day 1 to Day 28 ]
    Quality of life measured using EQ-5D-5L
  • Virus clearance/load (if samples are available) [ Time Frame: Day 1 to Day 28 ]
    Time to virus clearance and viral load
  • Blood and sputum biomarkers (if samples are available). [ Time Frame: Day 1 to Day 28 ]
    Blood and sputum biomarkers
  • Contact with health services (home setting only [ Time Frame: Day 1 to Day 28 ]
    Contact with health services
  • Consumption of antibiotics (home setting only [ Time Frame: Day 1 to Day 28 ]
    Consumption of antibiotics
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
  • Progression to pneumonia [ Time Frame: Day 2 to Day 28 ]
    Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment
  • Progression to pneumonia [ Time Frame: Day 1 to Day 28 ]
    Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment
  • Time to clinical improvement [ Time Frame: Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hours ]
    Time to clinical improvement
  • National Early Warning Score 2 (NEWS2) assessment of acute-illness severity [ Time Frame: Day 1 to Day 28 ]
    NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)
  • Changes in daily breathlessness, cough and sputum scale (BCSS) [ Time Frame: Day 1 to Day 28 ]
    Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)
  • Safety and tolerability - blood pressure II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at blood pressure measured in mmHg
  • Safety and tolerability - heart rate II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at heart rate measured in beats per minute
  • Safety and tolerability - temperature II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at temperature measured in degrees Celsius
  • Safety and tolerability - respiratory rate II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at respiratory rate measure in breaths per minute
  • Safety and tolerability - oxygen saturation II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at oxygen levels measured in a %
  • Safety and tolerability - adverse events II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at adverse events (numbers and terms)
  • Safety and tolerability - concomitant medications II. Viral load [ Time Frame: Day 1 to Day 28 ]
    Looking at concomitant medications given during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection
Official Title  ICMJE A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection
Brief Summary

SNG001 is an inhaled drug that contains a antiviral protein called interferon beta (IFN-β). IFN-β in produced in the lungs during viral lung infections. It has been shown that older people and people with some chronic diseases have an IFN-β deficiency. Many viruses inhibit IFN-β as part of their strategy to evade the immune system.

Addition of IFN-β in vitro protects lung cells from viral infection. IFN-β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19).

SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients.

Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has:

  • been well tolerated during virus infections
  • enhanced antiviral activity in the lungs (measured in sputum and blood samples)
  • provided significant lung function benefit over placebo in asthma in two Phase II trials.

Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients.

Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety.

The study will start as a Pilot phase where 100 patients will be randomised in the hospital setting and a 120 patients randomised in the home setting.

Once each of the Pilot phases are complete, a Pivotal phase will be conducted. It is estimated that the size of each of the Pivotal phases (hospital and home) will be around 100 to 300 patients per arm. The actual number will be determined after the data review at the end of each of the Pilot phases.

If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised double-blind placebo-controlled

Pilot phase - 100 patients randomised in the hospital setting, 120 patients randomised in the home setting.

Pivotal phase - estimated at an additional 100 to 300 patients per arm, but the actual number will be determined after the data review at the end of the Pilot phase

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Drug: SNG001
    SNG001 via inhalation
  • Drug: Placebo
    Placebo via inhalation
Study Arms  ICMJE
  • Active Comparator: SNG001
    inhalation using the I-neb device.
    Intervention: Drug: SNG001
  • Placebo Comparator: Placebo
    inhalation using the I-neb device.
    Intervention: Drug: Placebo
Publications * Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)
820
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2020)
400
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A. Hospital setting: positive virus test for SARS-CoV-2 using RT-PCR, or positive point-of-care viral infection test in the presence of strong clinical suspicion of SARS-CoV-2 infection.

    B. Home setting: positive virus test for SARS-CoV-2 using a molecular assay e.g. RT-PCR in the presence of strong clinical suspicion of SARS-CoV-2 infection.

  2. Male or female, ≥18 years of age (hospital setting) or ≥50 years of age (home setting) at the time of consent.
  3. A. Hospital setting: patients admitted to hospital due to the severity of their COVID 19 disease OR

    B. Home setting: non-hospitalised patients from high-risk groups, defined as ≥65-years of age, or ≥50 years of age and with any of the following risk factors:

    • Arterial hypertension
    • Cardiovascular disease
    • Diabetes mellitus
    • Chronic lung disease
    • Chronic kidney disease (eGFR <60 mL/min/1.73m2)
    • Chronic liver disease
    • Immunodeficiency due to a serious illness or medication
    • Cerebrovascular disease
    • Malignancy (except basal cell carcinoma) diagnosed in the last 5 years
    • Body Mass Index ≥30 who present with clinical symptoms consistent with COVID-19:
    • High temperature and/or
    • New, continuous cough.
    • Loss or change to sense of smell and/or taste
  4. Provide informed consent.
  5. A. Hospital setting: hospitalised female patients must be ≥1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.

B. Home setting: non-hospitalised female patients must be ≥1 year post-menopausal or surgically sterile.

Exclusion Criteria:

  1. > 24 hours after confirmation of SARS-CoV-2 infection by a molecular assay e.g. RT-PCR test (hospital and home settings) or >24 hours after a positive point-of-care viral infection test (hospital setting only). This criterion does not apply to patients in the hospital setting who had their positive RT-PCR test for SARS-CoV-2 performed prior to hospitalisation.
  2. >96 hours from onset of COVID-19 symptoms (cough and/or fever and/or loss or change to sense of smell and/or taste; home setting only).
  3. 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.
  4. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) 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.
  5. Ventilated or in intensive care.
  6. Inability to use a nebuliser with a mouthpiece.
  7. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
  8. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jody Brookes 02380512800 jody.brookes@synairgen.com
Contact: Sophie Hemmings 02380512800 sophie.hemmings@synairgen.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04385095
Other Study ID Numbers  ICMJE SG016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share data
Responsible Party Synairgen Research Ltd.
Study Sponsor  ICMJE Synairgen Research Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tom Wilkinson Study Principal Investigator
PRS Account Synairgen Research Ltd.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP