Status:
COMPLETED
Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection
Lead Sponsor:
Synairgen Research Ltd.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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.
- B. Home setting: non-hospitalised female patients must be ≥1 year post-menopausal or surgically sterile.
Exclusion
- \> 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.
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2021
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT04385095
Start Date
March 16 2020
End Date
November 16 2021
Last Update
January 4 2023
Active Locations (13)
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1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
2
Queen Elizabeth Hospital,
Birmingham, United Kingdom, B15 2GW
3
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
4
Park and St Francis Surgery
Chandler's Ford, United Kingdom, SO53 4ST