Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections

Arruda, Érico Antônio Gomes de; Pires-Neto, R.J.; Medeiros, M.S.; Quirino-Filho, J.; Clementino, Maria do Livramento Miranda; Gondim, R.N.D.G.; Magalhaes, Liamar; Cavalcante, K.F.; Viana, V.A.F.; Mello, Liana Perdigão; Martins, Ronaldo B.; Santos, Armênio Aguiar dos; Magalhães, Pedro J.C.; Havt, Alexandre; Lopes, Nelson; Arruda-Neto, E.; Lima, Aldo A. M.

doi:10.1101/2021.09.28.21264242

Cited by 5 publications

(10 citation statements)

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“…As of October 1, 2022, 119 preprints (78.3%) had been published in a scientific, peer-reviewed journal (Figure 2 and eTable 3 in Supplement 1). Two preprints were published in a single journal publication . The median time to publication was 186 days (range, 17-407 days).…”

Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.

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Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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“…The current prospective cross-sectional study is part of the ARTAN-C19 (Antiretroviral Nucleoside Analogue for COVID-19; ClinicalTrials.gov Identifier: NCT04712357) project, which is a type III, double-blind, randomized, placebo-controlled clinical trial that evaluated the effectiveness of tenofovir disoproxil fumarate (TDF) and TDF combined with emtricitabine (FTC) in patients with mild to moderate flu syndrome caused by SARS-CoV-2. 9 The study protocol and TCLE were approved by UFC/PROPESQ with the CAAE n°. 55952822.1.0000.5054.…”

Section: Study Design Site and Populationmentioning

confidence: 99%

“…In hospital practice, biomarkers can help in understanding the pathobiology, clinic, diagnosis, prognosis prediction, and in the development of risk stratification strategies for patients with COVID-19. 7,8 Our group has been carrying out studies with the population of patients with the disease COVID-19 in a profile of mild to moderate patients, 9 these data may help to better understand the role of inflammatory markers in this profile of patients. In this study, we evaluated the serum levels of a panel of immuno-inflammatory biomarkers in patients with mild to moderate flu syndrome with and without the presence of SARS-CoV-2 compared to healthy controls.…”

mentioning

confidence: 99%

Cytokines, chemokines, and cells growth factors in patients with mild to moderate SARS‐CoV‐2 infection: A case‐control study

Gondim,

de Arruda,

Neto

et al. 2023

Journal of Medical Virology

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Several biomarkers have been evaluated as predictors of severity or in directing the treatment of COVID‐19, however there are no conclusive results. In this study, we evaluated serum levels of cytokines, chemokines, and cell growth factors in association with the pathobiology of mild to moderate SARS‐CoV‐2 infection. Serum levels of SARS‐CoV‐2 infected patients (n = 113) and flu symptoms individuals negative for SARS‐CoV‐2 (n = 58), tested by the RT‐qPCR test—nasal swab were compared to healthy controls (n = 53). Results showed that the proinflammatory cytokines IL‐1β, MCP‐3, TNF‐α, and G‐CSF were increased in symptomatic patients and the cytokines IL‐6 and IL‐10 were associated with patients positive for SARS‐CoV‐2 when compared to healthy controls. Symptoms associated with COVID‐19 were fever, anosmia, ageusia, and myalgia. For patients without SARS‐CoV‐2 infection, their major symptom was sore throat. The pathobiology of mild to moderate SARS‐CoV‐2 infection was associated with increasing proinflammatory cytokines and a pleiotropic IL‐6 and anti‐inflammatory IL‐10 cytokines compared to healthy controls. Thus, knowledge about the pathophysiology and the involvement of biomarkers in the mild to moderate profile of the disease should be evaluated. Monitoring these biomarkers in patients with mild to moderate disease can help establish adequate treatment and prevention strategies for long‐term COVID‐19.

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“…Ten trials reported on hospital admissions, including 5575 patients with 252 events, with a median follow-up of 21 weeks. 3,30,35,39,42,48,53,55,56,67 Based on median risk in the placebo and standard care group, we assumed a risk of 54.4 hospital admissions per 1000.…”

Section: Hospital Admissionmentioning

confidence: 99%

Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis

Pitre

Alstine

Chick

et al. 2022

CMAJ

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Most trials addressing the treatment of patients with COVID-19 have targeted patients admitted to hospital with severe or critical disease. 1 However, more recently, several treatments, including antiviral drugs, antidepressants, monoclonal anti bodies and inhaled corticosteroids, have been studied for patients with nonsevere COVID-19. 2 Preliminary evidence from ongoing or recently completed trials suggests that 2 novel antiviral drugsmolnupiravir and nirmatrelvir-ritonavir (Paxlovid) -may be effective at reducing risk of hospital admission. [3][4][5] To date, evidence on antiviral drugs for nonsevere COVID-19 has not been systematically synthesized or appraised. Furthermore, although efficacy data from trials of molnupiravir, nirmatrelvir-ritonavir and remdesivir are promising, no head-to-head trials have compared these drugs.A network meta-analysis allows for comparison of treatments that have not been compared in randomized controlled trials (RCTs), using pooled estimates from direct and indirect evidence.They can provide guidance to clinicians and evidence users in determining which treatments are superior. This is particularly important as health care systems attempt to prioritize access to effective COVID-19 treatments in the early stages of the disease.We sought to compare the effectiveness of antiviral drugs for patients with nonsevere COVID-19. MethodsWe conducted a systematic review and network meta-analysis, that included a rigorous appraisal of the evidence. We registered a protocol on Open Science Framework and uploaded the data used for this analysis (https://osf.io/zbcf9). We report our systematic review and network meta-analysis in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension statement for reporting of sys tematic reviews incorporating network meta-analyses. 6

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Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections

Cited by 5 publications

References 50 publications

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Cytokines, chemokines, and cells growth factors in patients with mild to moderate SARS‐CoV‐2 infection: A case‐control study

Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis

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