Efficacy of Nitazoxanide in reducing the viral load in COVID-19 patients. Randomized, placebo-controlled, single-blinded, parallel group, pilot study.
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Abstract
The fast spread of COVID-19 has overcrowded Public Health Systems facilities in major countries due to the large number of seriously ill patients, particularly those requiring admission to intensive care units. Reducing viral load, along with other recommended epidemiological measures, such as social distancing and home confinement, can in time significantly help to reduce the infection R0 (Basic Reproductive Rate) and then mitigate disease burden. Early negativization or otherwise reduction of the viral load can potentially diminish disease severity, resulting in a better-controlled public health response, avoiding collapse of healthcare systems. Nitazoxanide, a widely used thiazolide approved by the FDA as an antiparasitic drug, also approved in Brazil for Norovirus and Rotavirus treatments, has an excellent safety record for a variety of indications. Nitazoxanide exhibits activity in vitro against MERS-CoV and other coronaviruses; and a specific antiviral effect (in micro molar doses) against SARS-CoV-2. The objective of this study was to evaluate the efficacy and safety of Nitazoxanide in reducing the SARS-COV 2 viral load within 7 days of treatment in respiratory samples from COVID-19-infected patients with mild to moderate disease, compared to placebo. An interim analysis showed that the ratio of patients with a viral load reduction ≥ 35% from baseline up to day 7 of treatment was significantly greater for Nitazoxanide compared to placebo (47.8% vs. 15.4%; Δ 34.6%; 95% CI: 64.7; 4.6: p = 0.037).
KEY POINTS
State of the Art
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Different studies conclude that viral load (VL) would correlate with morbidity, mortality and contagiousness of COVID-19.
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Early negativization or reduction of the viral load can potentially reduce the severity of this disease.
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In vitro data demonstrated a specific antiviral effect of Nitazoxanide for SARS-CoV-2.
Article contribution
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Nitazoxanide showed a statistically significant difference versus placebo in the number of patients who had their viral load reduced by at least 35% in mild to moderate COVID-19 disease.
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The observed antiviral effect in vitro would seems to be verified in patients with mild to moderate COVID-19 infection, which should be confirmed by studies with a larger cohort of patients.
Article activity feed
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SciScore for 10.1101/2021.03.03.21252509: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: The study was approved by the Institutional Evaluation Committee of the Faculty of Biomedical Sciences of the Universidad Austral.
Consent: All participating subjects gave their informed consent.Randomization This was a randomized, placebo-controlled, single-blinded, parallel-group, pilot study, carried out at Hospital Universitario Austral, and Sanatorio Nuestra Señora del Blinding not detected. Power Analysis not detected. Sex as a biological variable Pregnant or lactating women and subjects with any contraindication to the use of NTX (according to its package leaflet) were excluded. Table 2: Resources
Software and Algorithms Sentences Resources For the … SciScore for 10.1101/2021.03.03.21252509: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: The study was approved by the Institutional Evaluation Committee of the Faculty of Biomedical Sciences of the Universidad Austral.
Consent: All participating subjects gave their informed consent.Randomization This was a randomized, placebo-controlled, single-blinded, parallel-group, pilot study, carried out at Hospital Universitario Austral, and Sanatorio Nuestra Señora del Blinding not detected. Power Analysis not detected. Sex as a biological variable Pregnant or lactating women and subjects with any contraindication to the use of NTX (according to its package leaflet) were excluded. Table 2: Resources
Software and Algorithms Sentences Resources For the statistical analysis, the SPSS software (IBM version 16.0) was used. SPSSsuggested: (SPSS, RRID:SCR_002865)Results 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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04463264 Recruiting Efficacy and Safety Study of Nitazoxanide (NTX) in the Treat… 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.
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