Trials / Completed
CompletedNCT04732949
Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 623 (actual)
- Sponsor
- Synairgen Research Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.
Detailed description
Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNG001 | SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day |
| DRUG | Placebo | Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution |
Timeline
- Start date
- 2021-01-12
- Primary completion
- 2021-12-15
- Completion
- 2022-02-10
- First posted
- 2021-02-01
- Last updated
- 2023-03-27
- Results posted
- 2023-03-27
Locations
112 sites across 17 countries: United States, Argentina, Belgium, Brazil, Colombia, France, Germany, India, Israel, Italy, Mexico, Netherlands, Portugal, Romania, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04732949. Inclusion in this directory is not an endorsement.