SARS-CoV-2Phase 2NCT04385095
Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection
A Phase 2 study testing SNG001 in people with SARS-CoV-2, run by Synairgen Research Ltd. at 13 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- SNG001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 16 Mar 2020to 16 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
- 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
Show all 21Show fewer
- 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
- Provide informed consent.
- A. Hospital setting: hospitalised female patients must be ≥1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.
- Home setting: non-hospitalised female patients must be ≥1 year post-menopausal or surgically sterile.
Who cannot join
- > 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Belfast City Hospital
Belfast, BT9 7AB
Queen Elizabeth Hospital,
Birmingham, B15 2GW
Bradford Royal Infirmary
Bradford, BD9 6RJ
Park and St Francis Surgery
Chandler's Ford, SO53 4ST
Hull and East Yorkshire NHS Trust, Castle Hill Hospital,
Hull, HU16 5JQ
Glenfield Hospital,
Leicester, LE3 9QP
Wythenshawe Hospital
Manchester, M23 9LT
City Campus of Nottingham University
Nottingham, NG5 1PB
John Radcliffe Hospital
Oxford, OX3 9DU
The Adam Practice
Poole, BH15 2HX
The Virtual Team
Southampton, SO16 6YD
University Hospital Southampton Nhs Foundation Trust
Southampton, SO16 6YD
Oaks Healthcare
Waterlooville, PO8 8DL
About this study
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
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).
Read more
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
- Being tested
- SNG001, Placebo
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNG001Drug
SNG001 via inhalation
PlaceboDrug
Placebo via inhalation
| Study group | Role | What they receive |
|---|---|---|
| SNG001 | Active comparator | inhalation using the I-neb device. Receives: Drug: SNG001 |
| Placebo | Placebo comparator | inhalation using the I-neb device. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 to Days 15 and 28
Secondary outcomes (25)
Progression to pneumonia (hospital setting only)
Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment
Measured: Day 2 to Day 28
Progression to pneumonia (hospital setting only)
Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment
Measured: Day 1 to Day 28
Time to clinical improvement (hospital setting only)
Time to clinical improvement
Measured: 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)
NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)
Measured: Day 1 to Day 28
Changes in daily breathlessness, cough and sputum scale (BCSS)
Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)
Measured: Day 1 to Day 28 (and Day 60 and 90 home setting only)
Safety and tolerability - blood pressure (hospital setting only)
Looking at blood pressure measured in mmHg
Measured: Day 1 to Day 15
Safety and tolerability - heart rate
Looking at heart rate measured in beats per minute
Measured: Day 1 to Day 15
Safety and tolerability - temperature
Looking at temperature measured in degrees Celsius
Measured: Day 1 to Day 15
Safety and tolerability - respiratory rate (hospital setting only)
Looking at respiratory rate measure in breaths per minute
Measured: Day 1 to Day 15
Safety and tolerability - oxygen saturation
Looking at oxygen levels measured in a %
Measured: Day 1 to Day 15
Safety and tolerability - adverse events
Looking at adverse events (numbers and terms)
Measured: Day 1 to Day 28
Safety and tolerability - concomitant medications
Looking at concomitant medications given during treatment
Measured: Day 1 to Day 28
Time to clinical improvement (home setting only)
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
Measured: Day 1 to Day 15
Time to improvement of COVID-19 symptoms (home setting only).
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)
Measured: Day 1 to Day 28 and Day 60 and 90
Time to self-reported recovery (home setting only)
Time to self-reported recover
Measured: Day 2 to Day 15 and Day 28, 60 and 90
Self-reported daily rating of overall feeling of wellness (home setting only).
Self-reported daily rating of overall feeling of wellness scale from 1 (the worst you can imagine) to 10 (the best you can imagine)
Measured: Day 1 to Day 28 and Day 60 and 90
Quality of life measured using EQ-5D-5L (home setting only).
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
Measured: Day 1 to Day 28 and Day 60 and 90
Virus clearance/load (if samples are available)
Time to virus clearance and viral load
Measured: Day 1 to Day 28
Blood and sputum biomarkers (if samples are available).
Blood and sputum biomarkers
Measured: Day 1 to Day 28
Contact with health services (home setting only)
Contact with health services
Measured: Day 1 to Day 28
Consumption of antibiotics (home setting only)
Consumption of antibiotics
Measured: Day 1 to Day 28
General Anxiety Disorder 7 (home setting only)
Assessment of anxiety - score of 0 (best) to 3 (worst)
Measured: Day 60 and 90
Patient Health Questionnaire - 9
Assessment of mental health - score of 0 (best) to 3 (worst)
Measured: Day 60 and 90
FACIT Fatigue Scale
Assessment of Fatigue - score of 0 (best) to 4 (worst)
Measured: Day 60 and 90
Nottingham Extended Activities of Daily Living Scale
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'
Measured: Day 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start16 Mar 2020
- Primary completion17 Feb 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synairgen Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Wilkinson, Principal investigator, Study Chief InvestigatorNick Francis, Principal investigator, Study Deputy Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385095
- Sponsor's protocol ID
- SG016
- Status last verified
- Jan 2023
- First submitted
- 24 Apr 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Publications
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.
PubMed 33189161Lee 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.
PubMed 32788708
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04385095
- Acronym / sponsor ID
- SG016
- Conditions
- SARS-CoV-2
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Synairgen Research Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| SNG001 | Active comparator | Drug: SNG001inhalation using the I-neb device. |
| Placebo | Placebo comparator | Drug: Placeboinhalation using the I-neb device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- 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
- Provide informed consent.
- A. Hospital setting: hospitalised female patients must be ≥1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.
Key exclusion criteria (8 listed)
- > 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNG001SNG001 via inhalation | Drug | SNG001 |
| PlaceboPlacebo via inhalation | Drug | Placebo |
Primary outcome
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)
25 secondary outcomes
Progression to pneumonia (hospital setting only)
Time frame: Day 2 to Day 28
Progression to pneumonia (hospital setting only)
Time frame: Day 1 to Day 28
Time to clinical improvement (hospital setting only)
Time frame: 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)
Time frame: Day 1 to Day 28
Changes in daily breathlessness, cough and sputum scale (BCSS)
Time frame: Day 1 to Day 28 (and Day 60 and 90 home setting only)
Safety and tolerability - blood pressure (hospital setting only)
Time frame: Day 1 to Day 15
Safety and tolerability - heart rate
Time frame: Day 1 to Day 15
Safety and tolerability - temperature
Time frame: Day 1 to Day 15
Safety and tolerability - respiratory rate (hospital setting only)
Time frame: Day 1 to Day 15
Safety and tolerability - oxygen saturation
Time frame: Day 1 to Day 15
Safety and tolerability - adverse events
Time frame: Day 1 to Day 28
Safety and tolerability - concomitant medications
Time frame: Day 1 to Day 28
Time to clinical improvement (home setting only)
Time frame: Day 1 to Day 15
Time to improvement of COVID-19 symptoms (home setting only).
Time frame: Day 1 to Day 28 and Day 60 and 90
Time to self-reported recovery (home setting only)
Time frame: Day 2 to Day 15 and Day 28, 60 and 90
Self-reported daily rating of overall feeling of wellness (home setting only).
Time frame: Day 1 to Day 28 and Day 60 and 90
Quality of life measured using EQ-5D-5L (home setting only).
Time frame: Day 1 to Day 28 and Day 60 and 90
Virus clearance/load (if samples are available)
Time frame: Day 1 to Day 28
Blood and sputum biomarkers (if samples are available).
Time frame: Day 1 to Day 28
Contact with health services (home setting only)
Time frame: Day 1 to Day 28
Consumption of antibiotics (home setting only)
Time frame: Day 1 to Day 28
General Anxiety Disorder 7 (home setting only)
Time frame: Day 60 and 90
Patient Health Questionnaire - 9
Time frame: Day 60 and 90
FACIT Fatigue Scale
Time frame: Day 60 and 90
Nottingham Extended Activities of Daily Living Scale
Time frame: Day 60 and 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 33189161Monk 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.
- Derived from this study: PubMed 32788708Lee 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.
- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Wilkinson principal investigator
Study Chief Investigator
Nick Francis principal investigator
Study Deputy Chief Investigator
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNG001 in people with SARS-CoV-2, run by Synairgen Research Ltd. at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal Scale for Clinical Improvement (time frame: Day 1 to Days 15 and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385095, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.