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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385095
Recruitment Status : Active, not recruiting
First Posted : May 12, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Synairgen Research Ltd.

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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: SNG001 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 participants
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
Official Title: 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
Actual Study Start Date : March 16, 2020
Actual Primary Completion Date : February 17, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Active Comparator: SNG001
inhalation using the I-neb device.
Drug: SNG001
SNG001 via inhalation

Placebo Comparator: Placebo
inhalation using the I-neb device.
Drug: Placebo
Placebo via inhalation




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. Changes in daily breathlessness, cough and sputum scale (BCSS) [ Time Frame: Day 1 to Day 28 (and Day 60 and 90 home setting only) ]
    Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)

  6. Safety and tolerability - blood pressure (hospital setting only) [ Time Frame: Day 1 to Day 15 ]
    Looking at blood pressure measured in mmHg

  7. Safety and tolerability - heart rate [ Time Frame: Day 1 to Day 15 ]
    Looking at heart rate measured in beats per minute

  8. Safety and tolerability - temperature [ Time Frame: Day 1 to Day 15 ]
    Looking at temperature measured in degrees Celsius

  9. Safety and tolerability - respiratory rate (hospital setting only) [ Time Frame: Day 1 to Day 15 ]
    Looking at respiratory rate measure in breaths per minute

  10. Safety and tolerability - oxygen saturation [ Time Frame: Day 1 to Day 15 ]
    Looking at oxygen levels measured in a %

  11. Safety and tolerability - adverse events [ Time Frame: Day 1 to Day 28 ]
    Looking at adverse events (numbers and terms)

  12. Safety and tolerability - concomitant medications [ Time Frame: Day 1 to Day 28 ]
    Looking at concomitant medications given during treatment

  13. Time to clinical improvement (home setting only) [ Time Frame: Day 1 to Day 15 ]
    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

  14. Time to improvement of COVID-19 symptoms (home setting only). [ Time Frame: Day 1 to Day 28 and Day 60 and 90 ]
    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)

  15. Time to self-reported recovery (home setting only) [ Time Frame: Day 2 to Day 15 and Day 28, 60 and 90 ]
    Time to self-reported recover

  16. Self-reported daily rating of overall feeling of wellness (home setting only). [ Time Frame: Day 1 to Day 28 and Day 60 and 90 ]
    Self-reported daily rating of overall feeling of wellness scale from 1 (the worst you can imagine) to 10 (the best you can imagine)

  17. Quality of life measured using EQ-5D-5L (home setting only). [ Time Frame: Day 1 to Day 28 and Day 60 and 90 ]
    Quality of life measured using EQ-5D-5L - 5 questions where minimum score is 1 (best outcome) to 5 (worst outcome), visual analogue scale is also included for this 100 is best health you can imagine to 0 worst health you can imagine

  18. Virus clearance/load (if samples are available) [ Time Frame: Day 1 to Day 28 ]
    Time to virus clearance and viral load

  19. Blood and sputum biomarkers (if samples are available). [ Time Frame: Day 1 to Day 28 ]
    Blood and sputum biomarkers

  20. Contact with health services (home setting only) [ Time Frame: Day 1 to Day 28 ]
    Contact with health services

  21. Consumption of antibiotics (home setting only) [ Time Frame: Day 1 to Day 28 ]
    Consumption of antibiotics

  22. General Anxiety Disorder 7 (home setting only) [ Time Frame: Day 60 and 90 ]
    Assessment of anxiety - score of 0 (best) to 3 (worst)

  23. Patient Health Questionnaire - 9 [ Time Frame: Day 60 and 90 ]
    Assessment of mental health - score of 0 (best) to 3 (worst)

  24. FACIT Fatigue Scale [ Time Frame: Day 60 and 90 ]
    Assessment of Fatigue - score of 0 (best) to 4 (worst)

  25. Nottingham Extended Activities of Daily Living Scale [ Time Frame: Day 60 and 90 ]
    Assessment of activities of daily living - no score just tick the box that applies; 'Not at all', 'With help', 'On your own with difficulty' and 'On your own'



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:

  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. ≥ 8 days 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.

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): NCT04385095


Locations
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United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Queen Elizabeth Hospital,
Birmingham, United Kingdom, B15 2GW
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Park and St Francis Surgery
Chandler's Ford, United Kingdom, SO53 4ST
Hull and East Yorkshire NHS Trust, Castle Hill Hospital,
Hull, United Kingdom, HU16 5JQ
Glenfield Hospital,
Leicester, United Kingdom, LE3 9QP
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
City Campus of Nottingham University
Nottingham, United Kingdom, NG5 1PB
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
The Adam Practice
Poole, United Kingdom, BH15 2HX
The Virtual Team
Southampton, United Kingdom, SO16 6YD
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom, SO16 6YD
Oaks Healthcare
Waterlooville, United Kingdom, PO8 8DL
Sponsors and Collaborators
Synairgen Research Ltd.
Investigators
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Principal Investigator: Tom Wilkinson Study Chief Investigator
Principal Investigator: Nick Francis Study Deputy Chief Investigator
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Synairgen Research Ltd.
ClinicalTrials.gov Identifier: NCT04385095    
Other Study ID Numbers: SG016
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Synairgen Research Ltd.:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases