Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19

IntroductionThe SARS-CoV-2 outbreak has threatened the human population globally as the numbers of reinfection cases even after large-scale vaccination. Trials have been carried out to find drugs effective in fighting the disease, as COVID-19 is being considered a treatable disease only after we hav...

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Main Authors: Renato Martins da Silva, Paula Gebe Abreu Cabral, Sávio Bastos de Souza, Raul Ferraz Arruda, Sheila Passos de Figueiredo Cabral, Arícia Leone Evangelista Monteiro de Assis, Yolanda Porto Muniz Martins, Carlos Augusto de Araújo Tavares, Antônio Brazil Viana Junior, Junbiao Chang, Pingsheng Lei
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-03-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1143485/full
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author Renato Martins da Silva
Paula Gebe Abreu Cabral
Sávio Bastos de Souza
Raul Ferraz Arruda
Sheila Passos de Figueiredo Cabral
Arícia Leone Evangelista Monteiro de Assis
Yolanda Porto Muniz Martins
Carlos Augusto de Araújo Tavares
Antônio Brazil Viana Junior
Junbiao Chang
Pingsheng Lei
author_facet Renato Martins da Silva
Paula Gebe Abreu Cabral
Sávio Bastos de Souza
Raul Ferraz Arruda
Sheila Passos de Figueiredo Cabral
Arícia Leone Evangelista Monteiro de Assis
Yolanda Porto Muniz Martins
Carlos Augusto de Araújo Tavares
Antônio Brazil Viana Junior
Junbiao Chang
Pingsheng Lei
author_sort Renato Martins da Silva
collection DOAJ
description IntroductionThe SARS-CoV-2 outbreak has threatened the human population globally as the numbers of reinfection cases even after large-scale vaccination. Trials have been carried out to find drugs effective in fighting the disease, as COVID-19 is being considered a treatable disease only after we have antivirals. A clinical candidate originally developed for HIV treatment, AZVUDINE (FNC), is a promising drug in the treatment of COVID-19.MethodsTo predict the clinical outcome of COVID-19, we examined the course of viral load, every 48 h, by RT-PCR, and disease severity using an antiviral drug, FNC, with 281 participants. A randomized clinical trial was performed to evaluate the efficacy of FNC added to standard treatment, compared with placebo group added to standard treatment, for patients with mild COVID-19. RT-qPCR and ddPCR were applied to estimate the viral load in samples from patients. Also, the clinical improvement was evaluated as well as the liver and kidney function.Results and discussionNotably, the FNC treatment in the mild COVID-19 patients may shorten the time of the nucleic acid negative conversion (NANC) versus placebo group. In addition, the FNC was effective in reducing the viral load of these participants. The present clinical trial results showed that the FNC accelerate the elimination of the virus in and could reduce treatment time of mild patients and save a lot of medical resources, making it a strong candidate for the outpatient and home treatment of COVID-19.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05033145, identifier NCT05033145.
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spelling doaj.art-1b771fb61332433c92b4b3f72fa28d702023-03-15T13:42:25ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-03-011010.3389/fmed.2023.11434851143485Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19Renato Martins da Silva0Paula Gebe Abreu Cabral1Sávio Bastos de Souza2Raul Ferraz Arruda3Sheila Passos de Figueiredo Cabral4Arícia Leone Evangelista Monteiro de Assis5Yolanda Porto Muniz Martins6Carlos Augusto de Araújo Tavares7Antônio Brazil Viana Junior8Junbiao Chang9Pingsheng Lei10High Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilHigh Complexity Center, Galzu Institute, Campos dos Goytacazes, Rio de Janeiro, BrazilUniversidade Federal do Ceará (UFC)/Ebserh University Hospital Complex, Fortaleza, BrazilNMPA Key Laboratory for Research and Evaluation of Innovative Drug, Henan Normal University, Xinxiang, ChinaInstitute of Material Medical, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, ChinaIntroductionThe SARS-CoV-2 outbreak has threatened the human population globally as the numbers of reinfection cases even after large-scale vaccination. Trials have been carried out to find drugs effective in fighting the disease, as COVID-19 is being considered a treatable disease only after we have antivirals. A clinical candidate originally developed for HIV treatment, AZVUDINE (FNC), is a promising drug in the treatment of COVID-19.MethodsTo predict the clinical outcome of COVID-19, we examined the course of viral load, every 48 h, by RT-PCR, and disease severity using an antiviral drug, FNC, with 281 participants. A randomized clinical trial was performed to evaluate the efficacy of FNC added to standard treatment, compared with placebo group added to standard treatment, for patients with mild COVID-19. RT-qPCR and ddPCR were applied to estimate the viral load in samples from patients. Also, the clinical improvement was evaluated as well as the liver and kidney function.Results and discussionNotably, the FNC treatment in the mild COVID-19 patients may shorten the time of the nucleic acid negative conversion (NANC) versus placebo group. In addition, the FNC was effective in reducing the viral load of these participants. The present clinical trial results showed that the FNC accelerate the elimination of the virus in and could reduce treatment time of mild patients and save a lot of medical resources, making it a strong candidate for the outpatient and home treatment of COVID-19.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05033145, identifier NCT05033145.https://www.frontiersin.org/articles/10.3389/fmed.2023.1143485/fullCOVID-19SARS-CoV-2AZVUDINEFNCantiviral
spellingShingle Renato Martins da Silva
Paula Gebe Abreu Cabral
Sávio Bastos de Souza
Raul Ferraz Arruda
Sheila Passos de Figueiredo Cabral
Arícia Leone Evangelista Monteiro de Assis
Yolanda Porto Muniz Martins
Carlos Augusto de Araújo Tavares
Antônio Brazil Viana Junior
Junbiao Chang
Pingsheng Lei
Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
Frontiers in Medicine
COVID-19
SARS-CoV-2
AZVUDINE
FNC
antiviral
title Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
title_full Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
title_fullStr Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
title_full_unstemmed Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
title_short Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19
title_sort serial viral load analysis by ddpcr to evaluate fnc efficacy and safety in the treatment of mild cases of covid 19
topic COVID-19
SARS-CoV-2
AZVUDINE
FNC
antiviral
url https://www.frontiersin.org/articles/10.3389/fmed.2023.1143485/full
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