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Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection

NCT04385095 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2023-01-04

No results posted yet for this study

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 with some chronic diseases have an IFN-β deficiency. Many viruses inhibit IFN-β as part of their strategy to evade the immune system.

Addition of IFN-β in vitro protects lung cells from viral infection. IFN-β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19).

SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients.

Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving \>200 asthma and COPD patients. These trials have shown that SNG001 has:

* been well tolerated during virus infections
* enhanced antiviral activity in the lungs (measured in sputum and blood samples)
* provided significant lung function benefit over placebo in asthma in two Phase II trials.

Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients.

Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety.

The study will start as a Pilot phase where 100 patients will be randomised in the hospital setting and a 120 patients randomised in the home setting.

Once each of the Pilot phases are complete, a Pivotal phase will be conducted. It is estimated that the size of each of the Pivotal phases (hospital and home) will be around 100 to 300 patients per arm. The actual number will be determined after the data review at the end of each of the Pilot phases.

If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.

Conditions

Interventions

DRUG

SNG001

SNG001 via inhalation

DRUG

Placebo

Placebo via inhalation

Sponsors & Collaborators

  • Synairgen Research Ltd.

    lead INDUSTRY

Principal Investigators

  • Tom Wilkinson · Study Chief Investigator

  • Nick Francis · Study Deputy Chief Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2021-02-17
Completion
2021-11-16

Countries

  • 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 NCT04385095 on ClinicalTrials.gov