期刊
INTERNATIONAL FORUM OF ALLERGY & RHINOLOGY
卷 12, 期 9, 页码 1137-1147出版社
WILEY
DOI: 10.1002/alr.22975
关键词
epithelial cell; irrigations; surfactants; topical therapy for chronic rhinosinusitis; SARS-CoV-2; saline; virus
资金
- National Heart, Lung, and Blood Institute [P01 HL108808, R01 HL136961, UH3HL123645]
- National Institute of Allergy and Infectious Diseases [R01 AI108197, R21 AI142321, R21 AI142321-S1, U01AI151797]
- Cystic Fibrosis Foundation [BOUCHE19R0, BOUCHE19XX0, MIKAMI19XX0]
- National Institute of Diabetes and Digestive and Kidney Diseases [P30DK065988]
This study assessed the efficacy of a detergent-based virucidal agent in SARS-CoV-2-infected subjects and found that it had no impact on viral load or symptom scores in the clinical trial. Complementary in vitro studies confirmed this lack of efficacy, indicating a failure in drug absorption.
Background The 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. Methods Subjects 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. Results Seventy-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. Conclusion In 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.
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