Evidence map›Paper›PMID 35040594›Full record

Trial reportInternational forum of allergy & rhinology2022

Pharmacokinetic-based failure of a detergent virucidal for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nasal infections: A preclinical study and randomized controlled trial.

Charles R Esther, Kyle S Kimura, Yu Mikami, Caitlin E Edwards, Suman R Das, Michael H Freeman, Britton A Strickland, Hunter M Brown, Bronson C Wessinger, Veerain C Gupta and 12 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International forum of allergy & rhinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 32% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 2 institutions in 1 country.

Charles R EstherDivision of Pediatric Pulmonology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Kyle S KimuraDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Yu MikamiMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Caitlin E EdwardsDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Suman R DasDepartment of Medicine, Division of Microbiology and Infectious Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael H FreemanDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0002-5232-8695
Britton A StricklandDepartment of Medicine, Division of Microbiology and Infectious Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Hunter M BrownDepartment of Medicine, Division of Microbiology and Infectious Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Bronson C WessingerDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Veerain C GuptaDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Kate Von WahldeDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Quanhu ShengDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Li Ching HuangDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Daniel R BaconDepartment of Biology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-9267-1893
Adam J KimpleMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Agathe S CeppePulmonary and Critical Care Medicine, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Takafumi KatoMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Raymond J PicklesMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Scott H RandellMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Ralph S BaricDepartment of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Justin H TurnerDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0002-5501-9900
Richard C BoucherMarsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
University of North Carolina at Chapel Hill · USVanderbilt University Medical Center · US

Funding

UNC-CH CENTER FOR ENVIRONMENTAL HEALTH &SUSCEPTIBILITYP30ES010126 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Hazel B Nichols · 2001 to 2026
$36.3M
Vector CoreP30DK065988 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Scott H Randell · 2004 to 2026
$26.5M
The Biophysics of Mucus Hydration and Adhesion/CohesionP01HL108808 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOUCHER, RICHARD CHARLES · 2012 to 2021
$23.9M
North Carolina Translational and Clinical Science Institute (NC TraCS) KL2KL2TR002490 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WEINBERGER, MORRIS · 2018 to 2022
$11.0M
Determinants of Coronavirus Fidelity in Replication and PathogenesisR01AI108197 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BARIC, RALPH S, DENISON, MARK R · 2013 to 2022
$6.5M
Understanding Risk of Zoonotic Virus Emergence in EID Hotspots of Southeast AsiaU01AI151797 · NIAID · ECOHEALTH ALLIANCE, INC. · PI DASZAK, PETER · 2020 to 2023
$6.0M
Synthesis of Effective and Safe Mucolytics for Pulmonary DiseaseUH3HL123645 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOUCHER, RICHARD CHARLES · 2016 to 2018
$4.6M
Multiscale Biochemical/Biophysical Integration of Pulmonary Mucus TransportR01HL136961 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOUCHER, RICHARD CHARLES · 2017 to 2020
$3.2M
Integrated Metagenomic and Metatranscriptomic Characterization of Inflammatory Chronic Rhinosinusitis EndotypesR21AI142321 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DAS, SUMAN RANJAN, TURNER, JUSTIN H · 2020 to 2021
$924k
Elucidating the role of nasopharyngeal microbiome in Respiratory Syncytial Virus associated diseases in childrenR21AI149262 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DAS, SUMAN RANJAN · 2020 to 2021
$468k
NCATS NIH HHS KL2 TR002490NHLBI NIH HHS P01 HL108808NHLBI NIH HHS R01 HL136961NHLBI NIH HHS UH3 HL123645NIAID NIH HHS R01 AI108197NIAID NIH HHS R21 AI142321NIAID NIH HHS R21 AI149262NIAID NIH HHS U01 AI151797NIDDK NIH HHS P30 DK065988NIEHS NIH HHS P30 ES010126
6 · The paper itself

Abstract

backgroundThe nose is the portal for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection, suggesting the nose as a target for topical antiviral therapies. The purpose of this study was to assess both the in vivo and in vitro efficacy of a detergent-based virucidal agent, Johnson and Johnson's Baby Shampoo (J&J), in SARS-CoV-2-infected subjects.

methodsSubjects were randomized into three treatment groups: (1) twice daily nasal irrigation with J&J in hypertonic saline, (2) hypertonic saline alone, and (3) no intervention. Complementary in vitro experiments were performed in cultured human nasal epithelia. The primary outcome measure in the clinical trial was change in SARS-CoV-2 viral load over 21 days. Secondary outcomes included symptom scores and change in daily temperature. Outcome measures for in vitro studies included change in viral titers.

resultsSeventy-two subjects completed the clinical study (n = 24 per group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces.

conclusionIn this randomized clinical trial of subjects with SARS-CoV-2 infection, a topical detergent-based virucidal agent had no effect on viral load or symptom scores. Complementary in vitro studies confirmed a lack of efficacy, reflective of pharmacokinetic failure and rapid absorption from nasal surfaces.

Indexed as

Common ColdCOVID-19Antiviral AgentsDetergentsHumansSARS-CoV-2Viral LoadAntiviral AgentsDetergentsepithelial cellirrigationssalineSARS-CoV-2surfactantstopical therapy for chronic rhinosinusitisvirus

Identifiers

PMID35040594
PMCPMC9011886
OpenAlexW4205585552

What OpenQuestion holds

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Registered trials

None linked

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.