Randomized, Double-Blind, Placebo-Controlled Trial of a Throat Spray with Selected Lactobacilli in COVID-19 Outpatients
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Abstract
Viral respiratory tract infections result in significant health and economic burdens, as highlighted by the COVID-19 pandemic. Primary care patients represent 90% of those infected with SARS-CoV-2, yet their treatment options are limited to analgesics and antiphlogistics, and few broadly acting antiviral strategies are available.
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SciScore for 10.1101/2022.03.17.22272401: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Informed consent was obtained from all participants prior to inclusion. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Combined nose/throat swabs for microbiome analysis, determination of SARS-CoV-2 viral loads and detection of administered Lactobacillaceae strains via qPCR and MiSeq amplicon sequencing were self-sampled, as well as blood fingerprick samples (dried blood spots) to analyze SARS-CoV-2 IgG antibodies (Figure S1 and supplementary methods). SARS-CoV-2 IgGsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. …
SciScore for 10.1101/2022.03.17.22272401: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Informed consent was obtained from all participants prior to inclusion. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Combined nose/throat swabs for microbiome analysis, determination of SARS-CoV-2 viral loads and detection of administered Lactobacillaceae strains via qPCR and MiSeq amplicon sequencing were self-sampled, as well as blood fingerprick samples (dried blood spots) to analyze SARS-CoV-2 IgG antibodies (Figure S1 and supplementary methods). SARS-CoV-2 IgGsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our data on viral loads should be further substantiated, because our study had several limitations. In addition to the already discussed high biological variation of COVID-19 disease progression and the rather small study population, we also experienced a suboptimal timepoint of intervention. The start point appeared too late after disease onset. This has also been observed in other trials with antivirals for respiratory infections [24,25]. For local applications of probiotics or microbiome therapeutics [6] compared to oral applications such as [8], it is especially important that the antiviral bacteria are provided early enough in the viral infection process, considering the more local mode of action. Oral probiotics target the gut and systemic immunity to reduce symptoms in later phases [26]. Here, we had to rely on the standard government PCR testing procedures in Belgium, resulting in a delay between testing and inclusion. Most participants started within 2-5 days after their first symptoms, when the viral loads were highest. A study design with a more preventive set-up might be more suitable to evaluate a microbiome throat spray with a mode of action early in the viral infection process. Moreover, we also observed that most patients still experienced symptoms at the end of the monitoring (5% still reported acute symptoms, 39% systemic symptoms and 41% URT symptoms), so that follow-up work with any potential therapeutic or nutritional interventions in outpatients preferab...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04793997 Suspended Microbiome Therapy in Covid-19 Primary Care Support Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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