Evidence map›Paper›PMID 37855026›Full record

ArticleEClinicalMedicine2023

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 and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04518410 (Adaptive Platform Treatment Trial for Outpatients With COVID-19), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04518410 phase2 / phase3completednot on this map

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2023Enrolled4,044ConditionsCoronavirus, Covid19Armsbamlanivimab 7000mg, BRII-196+BRII-198, AZD7442 (IV), AZD7442 (IM), SNG001
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review: The Landscape of Antiviral Therapy for COVID-19 in the Era of Widespread Population Immunity and Omicron-Lineage Viruses.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 2 countries.

Prasanna JagannathanDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Kara W ChewDepartment of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA.
Mark J GigantiHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Michael D HughesHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Carlee MoserHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Mark J MainSynairgen Research Ltd, Southampton, United Kingdom.
Phillip D MonkSynairgen Research Ltd, Southampton, United Kingdom.
Arzhang Cyrus JavanNational Institutes of Health, Bethesda, MD, USA.
Jonathan Z LiDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Courtney V FletcherUniversity of Nebraska Medical Center, College of Pharmacy, USA.
Caitlyn McCarthyHarvard T.H. Chan School of Public Health, Boston, MA, USA.
David A WohlDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Eric S DaarLundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Joseph J EronDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Judith S CurrierDepartment of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA.
Upinder SinghDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Davey M SmithDepartment of Medicine, University of California, San Diego, La Jolla, CA, USA.
William FischerDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
ACTIV-2/A5401 Study Team
University of North Carolina at Chapel Hill · USHarvard University · USBrigham and Women's Hospital · USSynairgen (United Kingdom) · GBNational Institutes of Health · USStanford University · USUCLA Medical Center · USUniversity of California, Los Angeles · USUniversity of California San Diego · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
NCATS NIH HHS UL1 TR001881NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI106701
6 · The paper itself

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-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.govNCT04518410). 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. Funding: The ACTIV-2 platform study is funded by the NIH. Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI068636 and UM1 AI106701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Indexed as

ACTIV-2COVID-19Inhaled interferonRandomized clinical trialSARS-CoV-2

Identifiers

PMID37855026
PMCPMC10579289
OpenAlexW4387419326

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.