a trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients with COVID-19

Phase 1

• Conditions: COVID-19; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001023-14-GB
• Lead Sponsor: Synairgen Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-17
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Positive virus test for SARS-CoV-2

2. Male or female, =18 years of age at the time of consent

3. Patients admitted to hospital due to the severity of their COVID-19 disease OR non-hospitalised patients from high-risk co-morbidity groups such as the >65-years of age, or those with hypertension, cardiovascular disease, diabetes or a chronic lung condition

4. Provide written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1. > 24 hours after confirmation of SARS-CoV-2 infection

2. 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.

3. Current or previous participation in another clinical trial where the patient has received a dose of an 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.

4. Ventilated or in intensive care

5. Inability to use a nebuliser with a mouthpiece.

6. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation.

7. Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether SNG001 is well tolerated, and can prevent or accelerate recovery of lower respiratory tract illness in patients with SARS-CoV-2 infection.;Secondary Objective: To understand more about the biology of how SNG001 affects patients and the virus infection, this will be done by assessing changes in biomarkers in blood and sputum if they are available.;Primary end point(s): Primary Endpoint:<br>Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period.<br><br>The Ordinal Scale for Clinical Improvement is a World Health Organisation recommended scale for use in COVID-19 trials.<br>;Timepoint(s) of evaluation of this end point: The dosing period is 14 days. Changes in the ordinal scale during the dosing period will be assessed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present <br> at time of enrolment <br>b. Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at <br> time of enrolment <br>c. Time to clinical resolution =4 of 5 vital signs (temperature, O2 sats, Resp <br> rate, heart rate, systolic blood pressure).<br>d. LRT Symptoms (Changes in daily symptoms breathlessness, cough and sputum scale <br> (BCSS) symptoms score during the study period (including disaggregated scores))<br>e. Virus clearance/load<br>f. Safety and tolerability <br>g. Blood and sputum biomarkers if samples are available;Timepoint(s) of evaluation of this end point: During the 14 day dosing period.