Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial

Prasanna Jagannathan; Kara W. Chew; Mark J. Giganti; Michael D. Hughes; Carlee Moser; Mark J. Main; Phillip D. Monk; Arzhang Cyrus Javan; Jonathan Z. Li; Courtney V. Fletcher; Caitlyn McCarthy; David A. Wohl; Eric S. Daar; Joseph J. Eron; Judith S. Currier; Upinder Singh; Davey M. Smith; William Fischer; ACTIV 2 A5401 Study Team

doi:10.1016/j.eclinm.2023.102250

Back

Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial

Journal article

Open access

Peer reviewed

Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial

Prasanna Jagannathan, Kara W. Chew, Mark J. Giganti, Michael D. Hughes, Carlee Moser, Mark J. Main, Phillip D. Monk, Arzhang Cyrus Javan, Jonathan Z. Li, Courtney V. Fletcher, …

EClinicalMedicine, Vol.65, pp.102250-102250

11/01/2023

DOI: 10.1016/j.eclinm.2023.102250

PMID: 37855026

Files and links (1)

url

https://doi.org/10.1016/j.eclinm.2023.102250View

Published (Version of record) Open Access

Abstract

Background With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need. Methods Safety, clinical and antiviral efficacy of inhaled interferon-beta 1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.gov NCT04518410). Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized and initiated either orally inhaled nebulized SNG001 given once daily for 14 days (n = 110) or blinded pooled placebo (n = 110) between February 10 and August 18, 2021. Findings The proportion of participants reporting premature treatment discontinuation was 9% among SNG001 and 13% among placebo participants. There were no differences between participants who received SNG001 or placebo in the primary outcomes of treatment emergent Grade 3 or higher adverse events (3.6% and 8.2%, respectively), time to symptom improvement (median 13 and 9 days, respectively), or proportion with unquantifiable nasopharyngeal SARS-CoV-2 RNA at days 3 (28% [26/93] vs. 39% [37/94], respectively), 7 (65% [60/93] vs. 66% [62/94]) and 14 (91% [86/95] vs. 91% [83/81]). There were fewer hospitalizations with SNG001 (n = 1; 1%) compared with placebo (n = 7; 6%), representing an 86% relative risk reduction (p = 0.07). There were no deaths in either arm. Interpretation In this trial, SNG001 was safe and associated with a non-statistically significant decrease in hospitalization for COVID-19 pneumonia. Copyright (c) 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

General & Internal Medicine

Life Sciences & Biomedicine

Medicine, General & Internal

Science & Technology

Details

Title: Subtitle: Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial
Creators: Prasanna Jagannathan - Stanford Medicine
Kara W. Chew - University of California, Los Angeles
Mark J. Giganti - Harvard University
Michael D. Hughes - Harvard University
Carlee Moser - Harvard University
Mark J. Main - Synairgen (United Kingdom)
Phillip D. Monk - National Institutes of Health
Arzhang Cyrus Javan - National Institutes of Health
Jonathan Z. Li - Brigham and Women's Hospital
Courtney V. Fletcher - University of Nebraska Medical Center
Caitlyn McCarthy - Harvard University
David A. Wohl - University of North Carolina at Chapel Hill
Eric S. Daar - University of North Carolina at Chapel Hill
Joseph J. Eron - University of North Carolina at Chapel Hill
Judith S. Currier - University of California, Los Angeles
Upinder Singh - University of California San Diego
Davey M. Smith - University of California San Diego
William Fischer - University of North Carolina at Chapel Hill
ACTIV 2 A5401 Study Team
Resource Type: Journal article
Publication Details: EClinicalMedicine, Vol.65, pp.102250-102250
DOI: 10.1016/j.eclinm.2023.102250
PMID: 37855026
NLM abbreviation: EClinicalMedicine
ISSN: 2589-5370
eISSN: 2589-5370
Publisher: Elsevier
Number of pages: 12
Grant note: UM1AI106701 / National Institute of Allergy and Infectious Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) UM1AI068636 / National Institute of Neurological Disorders and Stroke; National Institute on Drug Abuse; National Institute of Allergy and Infectious Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Neurological Disorders & Stroke (NINDS); NIH National Institute on Drug Abuse (NIDA); NIH National Institute of Allergy & Infectious Diseases (NIAID) UM1 AI068634; UM1 AI068636; UM1 AI106701 / National Institute of Allergy and Infectious Diseases of the National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA UM1AI069424 / National Institute on Drug Abuse; National Institute of Allergy and Infectious Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute on Drug Abuse (NIDA); NIH National Institute of Allergy & Infectious Diseases (NIAID)
Language: English
Date published: 11/01/2023
Academic Unit: Internal Medicine
Record Identifier: 9985244650602771

Metrics

1 Record Views

12 Times Cited - Web of Science