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Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT04732949•Synairgen Research Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Admitted to hospital due to the severity of their COVID-19
•Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
•Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
•Provided informed consent
•Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
•Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy
•Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women \<50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.

Exclusion Criteria

•Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
•Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
•Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care
•Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
•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
•Participation in previous clinical trials of SNG001
•Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product 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
•Inability to use a nebuliser with a mouthpiece
•Inability to comply with the requirements for storage conditions of study medication in the home setting
•History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation
+1 more criteria

Locations (112)

The University of Arizona Medi

Tucson, Arizona, United States

Professional Health Care of Pi

St. Petersburg, Florida, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Icahn School of Medicine at Mo

New York, New York, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Ciudad Autónoma de Buenos Air, Buenos Aires, Argentina

Hospital Universitario Austral

Buenos Aires, Argentina

Hospital Papa Francisco - Hosp

Salta, Argentina

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

Key Dates

Start Date

January 12, 2021

Primary Completion Date

December 15, 2021

Completion Date

February 10, 2022

Last Updated

March 27, 2023

Enrollment

623

ACTUAL participants

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2COVID-19

Interventions

SNG001

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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