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

NCT04385095 | Completed Phase 2 DMC

• 1 other identifier: SG016
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 13

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.

Conditions

SARS-CoV-2

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Ordinal Scale for Clinical Improvement

  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)

  Day 1 to Days 15 and 28

Secondary Outcomes (25)

• Progression to pneumonia (hospital setting only)

  Day 2 to Day 28

• Progression to pneumonia (hospital setting only)

  Day 1 to Day 28

• Time to clinical improvement (hospital setting only)

  Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hours

• National Early Warning Score 2 (NEWS2) assessment of acute-illness severity (hospital setting only)

  Day 1 to Day 28

• Changes in daily breathlessness, cough and sputum scale (BCSS)

  Day 1 to Day 28 (and Day 60 and 90 home setting only)

Study Arms (2)

SNG001

ACTIVE COMPARATOR

inhalation using the I-neb device.

Drug: SNG001

Placebo

PLACEBO COMPARATOR

inhalation using the I-neb device.

Drug: Placebo

Interventions

SNG001 DRUG

SNG001 via inhalation

SNG001

Placebo DRUG

Placebo via inhalation

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female, ≥18 years of age (hospital setting) or ≥50 years of age (home setting) at the time of consent.
• 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:

You may not qualify if:

• \> 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.
• ≥ 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).
• 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.
• 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.
• Ventilated or in intensive care.
• Inability to use a nebuliser with a mouthpiece.
• 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.

Sponsors & Collaborators

• Synairgen Research Ltd.: lead

Study Sites (13)

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Queen Elizabeth Hospital,

Birmingham, B15 2GW, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Park and St Francis Surgery

Chandler's Ford, SO53 4ST, United Kingdom

Location

Hull and East Yorkshire NHS Trust, Castle Hill Hospital,

Hull, HU16 5JQ, United Kingdom

Location

Glenfield Hospital,

Leicester, LE3 9QP, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

City Campus of Nottingham University

Nottingham, NG5 1PB, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

The Adam Practice

Poole, BH15 2HX, United Kingdom

Location

The Virtual Team

Southampton, SO16 6YD, United Kingdom

Location

University Hospital Southampton Nhs Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Oaks Healthcare

Waterlooville, PO8 8DL, United Kingdom

Location

Related Publications (2)

• Monk PD, Marsden RJ, Tear VJ, Brookes J, Batten TN, Mankowski M, Gabbay FJ, Davies DE, Holgate ST, Ho LP, Clark T, Djukanovic R, Wilkinson TMA; Inhaled Interferon Beta COVID-19 Study Group. Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021 Feb;9(2):196-206. doi: 10.1016/S2213-2600(20)30511-7. Epub 2020 Nov 12.

  PMID: 33189161 DERIVED

• 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.

  PMID: 32788708 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tom Wilkinson

  Study Chief Investigator

  PRINCIPAL INVESTIGATOR

• Nick Francis

  Study Deputy Chief Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 12, 2020
• Study Start: March 16, 2020
• Primary Completion: February 17, 2021
• Study Completion: November 16, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (13)