COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04385095

Tom Wilkinson

t.wilkinson@soton.ac.uk

2020-05-12

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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.

> 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.

2

Synairgen Research Ltd.

18

None

United Kingdom

No restriction on type of patients

0: No restriction on type of patients

221

Ordinal Scale for Clinical Improvement

None

Phase 2

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