Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

NCT04732949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2023-03-27

Study results available
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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.

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2
  • COVID-19

Interventions

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

Sponsors & Collaborators

  • Synairgen Research Ltd.

    lead INDUSTRY

Principal Investigators

  • Professor Tom Wilkinson · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2021-12-15
Completion
2022-02-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Colombia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732949 on ClinicalTrials.gov