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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||820 participants|
|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)|
|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|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Active Comparator: SNG001
inhalation using the I-neb device.
SNG001 via inhalation
Placebo Comparator: Placebo
inhalation using the I-neb device.
Placebo via inhalation
- 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)
- 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
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
|Contact: Jody Brookesfirstname.lastname@example.org|
|Contact: Sophie Hemmingsemail@example.com|
|Belfast City Hospital||Not yet recruiting|
|Belfast, United Kingdom, BT9 7AB|
|Contact: Lorcan McGarvey, MD FRCP|
|Queen Elizabeth Hospital,||Recruiting|
|Birmingham, United Kingdom, B15 2GW|
|Contact: Davinder Dosanjh, DPhil, MRCP, FHEA|
|Bradford Royal Infirmary||Recruiting|
|Bradford, United Kingdom, BD9 6RJ|
|Contact: Dinesh Saralaya, MBBS MD MRCP FRCP|
|Hull and East Yorkshire NHS Trust, Castle Hill Hospital,||Recruiting|
|Hull, United Kingdom, HU16 5JQ|
|Contact: Michael Crooks, MBBS|
|Leicester, United Kingdom, LE3 9QP|
|Contact: Salman Siddiqui, Fellow of the Royal College of|
|Manchester, United Kingdom, M23 9LT|
|Contact: Jaclyn Smith, MB ChB MRCP PhD FRCP|
|City Campus of Nottingham University||Recruiting|
|Nottingham, United Kingdom, NG5 1PB|
|Contact: Tim Harrison, MBBS FRCP MD|
|John Radcliffe Hospital||Recruiting|
|Oxford, United Kingdom, OX3 9DU|
|Contact: Najib Rahman, MB BCh MA|
|University Hospital Southampton Nhs Foundation Trust||Recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Contact: Tom Wilkinson firstname.lastname@example.org|
|Principal Investigator: Tom Wilkinson|
|Principal Investigator:||Tom Wilkinson||Study Principal Investigator|