Evidence map›Paper›PMID 33569576›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study.

Roy F Chemaly, Francisco M Marty, Cameron R Wolfe, Steven J Lawrence, Sanjeet Dadwal, Rosemary Soave, Jason Farthing, Stephen Hawley, Paul Montanez, Jimmy Hwang and 4 more

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

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01644877 (A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

NCT01644877 phase2completednot on this map

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen

TypeinterventionalSponsorAnsun Biopharma, Inc.Ran2014 to 2016Enrolled111ConditionsParainfluenzaArmsDAS181 dry powder, formulation F02, Lactose Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 29 citations in OpenAlex.

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  17. Broad-spectrum Respiratory Virus Entry Inhibitors.Advances in experimental medicine and biology · 2022
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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

14 authors at 7 institutions in 1 country.

Roy F ChemalyDepartment of Infectious Diseases, Infection Control & Employee Health, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Francisco M MartyDana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts, USA.
Cameron R WolfeDivision of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA.
Steven J LawrenceDivision of Infectious Diseases, Washington University School of Medicine, St. Louis, Missouri, USA.
Sanjeet DadwalDepartment of Infectious Disease, City of Hope, Duarte, California, USA.
Rosemary SoaveNew York-Presbyterian Hospital and Weill Cornell Medical Center, New York, New York, USA.
Jason FarthingAnsun Biopharma, San Diego, California, USA.
Stephen HawleyAnsun Biopharma, San Diego, California, USA.
Paul MontanezAnsun Biopharma, San Diego, California, USA.
Jimmy HwangAnsun Biopharma, San Diego, California, USA.
Jennifer Hui-Chun HoAnsun Biopharma, San Diego, California, USA.
Stanley LewisAnsun Biopharma, San Diego, California, USA.
George WangAnsun Biopharma, San Diego, California, USA.
Michael BoeckhVaccine and Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Brigham and Women's Hospital · USCity of Hope · USDuke Medical Center · USFred Hutch Cancer Center · USNew York Hospital Queens · USThe University of Texas MD Anderson Cancer Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are no antiviral therapies for parainfluenza virus (PIV) infections. DAS181, a sialidase fusion protein, has demonstrated activity in in vitro and in animal models of PIV.

methodsAdult immunocompromised patients diagnosed with PIV lower respiratory tract infection (LRTI) who required oxygen supplementation were randomized 2:1 to nebulized DAS181 (4.5 mg/day) or matching placebo for up to 10 days. Randomization was stratified by need for mechanical ventilation (MV) or supplemental oxygen (SO). The primary endpoint was the proportion of patients reaching clinical stability survival (CSS) defined as returning to room air (RTRA), normalization of vital signs for at least 24 hours, and survival up to day 45 from enrollment.

resultsA total of 111 patients were randomized to DAS181 (n = 74) or placebo (n = 37). CSS was achieved by 45.0% DAS181-treated patients in the SO stratum compared with 31.0% for placebo (P = .15), whereas patients on MV had no benefit from DAS181. The proportion of patients achieving RTRA was numerically higher for SO stratum DAS181 patients (51.7%) compared with placebo (34.5%) at day 28 (P = .17). In a post hoc analysis of solid organ transplant, hematopoietic cell transplantation within 1 year, or chemotherapy within 1 year, more SO stratum patients achieved RTRA on DAS181 (51.8%) compared with placebo (15.8%) by day 28 (P = .012).

conclusionsThe primary endpoint was not met, but post hoc analysis of the RTRA component suggests DAS181 may have clinical activity in improving oxygenation in select severely immunocompromised patients with PIV LRTI who are not on mechanical ventilation. Clinical Trials Registration. NCT01644877.

Indexed as

Paramyxoviridae InfectionsRespiratory Tract InfectionsAdultAnimalsHumansImmunocompromised HostLungRecombinant Fusion ProteinsoplunofuspRecombinant Fusion ProteinsDAS181immunocompromisedlower respiratory tract infectionsparainfluenza virussupplemental oxygen

Identifiers

PMID33569576
PMCPMC8326557
OpenAlexW3126465298

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.