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


Journal article


A. Lima, E. Arruda, R. J. Pires-Neto, M. Medeiros, J. Quirino-Filho, M. Clementino, R. D. Gondim, L. M. C. Magalhães, K. F. Cavalcante, V. A. F. Viana, L. Perdigão, P. Magalhães, A. A. Santos, R. Martins, A. Havt, N. Lopes, E. Arruda-Neto
medRxiv, 2021

Semantic Scholar DOI
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APA   Click to copy
Lima, A., Arruda, E., Pires-Neto, R. J., Medeiros, M., Quirino-Filho, J., Clementino, M., … Arruda-Neto, E. (2021). Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections. MedRxiv.


Chicago/Turabian   Click to copy
Lima, A., E. Arruda, R. J. Pires-Neto, M. Medeiros, J. Quirino-Filho, M. Clementino, R. D. Gondim, et al. “Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections.” medRxiv (2021).


MLA   Click to copy
Lima, A., et al. “Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections.” MedRxiv, 2021.


BibTeX   Click to copy

@article{a2021a,
  title = {Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections},
  year = {2021},
  journal = {medRxiv},
  author = {Lima, A. and Arruda, E. and Pires-Neto, R. J. and Medeiros, M. and Quirino-Filho, J. and Clementino, M. and Gondim, R. D. and Magalhães, L. M. C. and Cavalcante, K. F. and Viana, V. A. F. and Perdigão, L. and Magalhães, P. and Santos, A. A. and Martins, R. and Havt, A. and Lopes, N. and Arruda-Neto, E.}
}

Abstract

This study aimed to evaluate the efficacy and toxicity of tenofovir (TDF) and TDF combined with emtricitabine (TDF/FTC) in patients with mild to moderate COVID-19 infections. We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with clinical suspicion of mild to moderate respiratory infection caused by SARS-CoV-2 who were treated at an outpatient clinic. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo Vitamin C (500 mg/day). The primary parameter was the score of symptoms and predictive signs of COVID-19, assessed on the seventh day of patient follow-up. From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF group; (b) 74 in the TDF combined with FTC group; and (c) 77 in the Vitamin C group (placebo). Of the 226 patients, 139 (62%) were positive for SARS-CoV-2. Fever (37.8oC), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical symptoms or signs were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical symptoms and signs between treatment groups. Patients with mild to moderate infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1{beta}, IL-6 and TNF- compared to patients without infection. Patients with mild to moderate respiratory infection, with fever (37.8oC), loss of smell, loss of taste and two or more symptoms, have a better prediction for the diagnosis of COVID-19. Patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score in mild to moderate respiratory infection in patients with SARS-CoV-2 compared to the Vitamin C group (placebo).


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