Randomized, Double-Blind, Placebo-Controlled Trial of a Throat Spray with Selected Lactobacilli in COVID-19 Outpatients

Primary care urgently needs treatments for coronavirus disease 2019 (COVID-19) patients because current options are limited, while these patients who do not require hospitalization encompass more than 90% of the people infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here,...

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Published in:Microbiology spectrum 2022-10, Vol.10 (5), p.e0168222
Main Authors: De Boeck, Ilke, Cauwenberghs, Eline, Spacova, Irina, Gehrmann, Thies, Eilers, Tom, Delanghe, Lize, Wittouck, Stijn, Bron, Peter A, Henkens, Tim, Gamgami, Imane, Simons, Alix, Claes, Ingmar, Mariën, Joachim, Ariën, Kevin K, Bakokimi, Diana, Loens, Katherine, Jacobs, Kevin, Ieven, Margareta, Bruijning-Verhagen, Patricia, Delputte, Peter, Coenen, Samuel, Verhoeven, Veronique, Lebeer, Sarah
Format: Article
Language:English
Subjects:
Antiviral Agents - therapeutic use
COVID-19
COVID-19 Drug Treatment
COVID-19 Testing
Host-Microbial Interactions
Humans
lactobacilli
Lactobacillus
microbiome
Oral Sprays
Outpatients
Pandemics - prevention & control
Pharynx
Research Article
SARS-CoV-2
throat spray
Treatment Outcome
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Summary:Primary care urgently needs treatments for coronavirus disease 2019 (COVID-19) patients because current options are limited, while these patients who do not require hospitalization encompass more than 90% of the people infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here, we evaluated a throat spray containing three strains with broad antiviral properties in a randomized, double-blind, placebo-controlled trial. Before the availability of vaccines, 78 eligible COVID-19 patients were randomized to verum (  = 41) and placebo (  = 37) within 96 h of a positive PCR-based SARS-CoV-2 diagnosis, and a per-protocol analysis was performed. Symptoms and severity were reported daily via an online diary. Combined nose-throat swabs and dried blood spots were collected at regular time points in the study for microbiome, viral load, and antibody analyses. The daily reported symptoms were highly variable, with no added benefit for symptom resolution in the verum group. However, based on 16S V4 amplicon sequencing, the acute symptom score (fever, diarrhea, chills, and muscle pain) was significantly negatively associated with the relative abundance of amplicon sequence variants (ASVs) that included the applied lactobacilli (  
ISSN:2165-0497
2165-0497
DOI:10.1128/spectrum.01682-22