Evidence map›Paper›PMID 23045618›Full record

Trial reportThe Journal of infectious diseases2012

A phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection.

Ronald B Moss, Carrie Hansen, Rebecca L Sanders, Stephen Hawley, Tiejun Li, Roy T Steigbigel

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01037205 (Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza), which is not on this map. Cited by 84 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 1 pooled it
9.9field-weighted citation impact, top 1% 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.

NCT01037205 phase2completednot on this map

Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza

TypeinterventionalSponsorAnsun Biopharma, Inc.Ran2009 to 2011Enrolled264ConditionsInfluenzaArmsDAS181 dry powder, formulation F02, Respitose ML006 (DMV-Fonterra)
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 1 synthesis or guideline pooled it, 148 citations in OpenAlex.

  1. Pooled it
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  17. Principles and Therapeutics ofJournal of pharmacy & bioallied sciences · 2024
    Review
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24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Ronald B MossNexBio Inc, San Diego California 92121, USA. rmoss@nexbio.com
Carrie Hansen
Rebecca L Sanders
Stephen Hawley
Tiejun Li
Roy T Steigbigel
Nexen (Canada) · CAStony Brook University · US

Funding

PHS HHS DMID-06-35
6 · The paper itself

Abstract

backgroundDAS181, a novel host-directed antiviral in development for influenza treatment, was assessed in this phase II clinical trial.

methodsThis study was a double-blind, placebo-controlled phase II clinical trial assessing influenza viral load and patient safety in otherwise healthy influenza-infected participants. Participants were randomized to a single-dose, multiple-dose, or placebo group and were followed for safety and virologic outcomes.

resultsA total of 177 laboratory-confirmed influenza-infected participants were enrolled in the trial, which encompassed 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemispheres. Thirty-seven percent of participants had confirmed infection with influenza B, 33% with seasonal H3N2, 29% with pandemic 2009 H1N1, and 1 participant was positive for both influenza B and pandemic 2009 H1N1. Significant effects were observed in regard to decreased change from baseline viral load and viral shedding in the multiple-dose group compared with placebo as measured by quantitative polymerase chain reaction (P < .05). No instances of H274Y were observed among viral isolates from this trial. Overall, the drug was generally well tolerated.

conclusionsDAS181 significantly reduced viral load in participants infected with influenza, thus warranting future clinical development of this novel host-directed therapy. CLINICAL TRIALS.GOV IDENTIFIER: NCT01037205.

Indexed as

AdultAntiviral AgentsDouble-Blind MethodFemaleHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza, HumanMaleMiddle AgedPlacebosRecombinant Fusion ProteinsTreatment OutcomeViral LoadAntiviral AgentsoplunofuspPlacebosRecombinant Fusion Proteins

Identifiers

PMID23045618
PMCPMC3570175
OpenAlexW2133718742

What OpenQuestion holds

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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.