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Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients
BACKGROUND: In 2019, a highly pathogenic coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surfaced and resulted in the outbreak of coronavirus disease 2019 (COVID-19). With the aim of finding effective drugs to fight against the disease, several trials have been conduct...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10620601/ https://www.ncbi.nlm.nih.gov/pubmed/37928473 http://dx.doi.org/10.3389/fmed.2023.1215916 |
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author | de Souza, Sávio Bastos Cabral, Paula Gebe Abreu da Silva, Renato Martins Arruda, Raul Ferraz Cabral, Sheila Passos de Figueiredo de Assis, Arícia Leone Evangelista Monteiro Viana Junior, Antônio Brazil Degrave, Wim Maurits Sylvain Moreira, Aline dos Santos Silva, Cléber Glória Chang, Junbiao Lei, Pingsheng |
author_facet | de Souza, Sávio Bastos Cabral, Paula Gebe Abreu da Silva, Renato Martins Arruda, Raul Ferraz Cabral, Sheila Passos de Figueiredo de Assis, Arícia Leone Evangelista Monteiro Viana Junior, Antônio Brazil Degrave, Wim Maurits Sylvain Moreira, Aline dos Santos Silva, Cléber Glória Chang, Junbiao Lei, Pingsheng |
author_sort | de Souza, Sávio Bastos |
collection | PubMed |
description | BACKGROUND: In 2019, a highly pathogenic coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surfaced and resulted in the outbreak of coronavirus disease 2019 (COVID-19). With the aim of finding effective drugs to fight against the disease, several trials have been conducted since COVID-19 can only be considered a treatable disease, from a clinical point of view, after the availability of specific and effective antivirals. AZVUDINE (FNC), initially developed for treating HIV, is a potential treatment for COVID-19 as it has the capability to lower the patient’s viral load and promote recovery. METHODS: Volunteers infected with SARS-CoV-2 confirmed by reverse transcription polymerase chain reaction (RT-PCR), with good kidney and liver function, who were not using other antivirals or monoclonal antibodies were eligible. Samples from patients were assessed for viral load every 48 h during treatment using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and droplet digital polymerase chain reaction (ddPCR). RESULTS: The study’s primary outcome measure was the percentage of participants showing an improvement in clinical scores, while the secondary outcome measure was the percentage of participants with a clinical outcome of cure. These measures were used to assess the safety and efficacy of FNC for treating COVID-19. In the analysis of sociodemographic variables, no significant differences were detected between patients in the FNC and the placebo group for race, age group, or sex. The results showed a potential benefit to participants who received FNC during the study, as observed in the shorter hospital stay, shorter negative conversion time of SARS-CoV-2, and a significant reduction in viral load. Furthermore, the reduction in fever and chills were significant at D1, D2, and D3. In this study, a total of 112 adverse events cases were noted, with 105 cases being categorized as non-serious and only 7 cases as serious adverse events. CONCLUSION: The pandemic is not being effectively controlled and is causing multiple waves of infection that require extensive medical resources. However, FNC has demonstrated potential to reduce the treatment duration of moderate COVID-19 cases, thereby saving significant medical resources. This makes FNC a promising candidate for COVID-19 treatment. Clinical trial registration: [clinicaltrials.gov], identifier [NCT04668235]. |
format | Online Article Text |
id | pubmed-10620601 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-106206012023-11-03 Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients de Souza, Sávio Bastos Cabral, Paula Gebe Abreu da Silva, Renato Martins Arruda, Raul Ferraz Cabral, Sheila Passos de Figueiredo de Assis, Arícia Leone Evangelista Monteiro Viana Junior, Antônio Brazil Degrave, Wim Maurits Sylvain Moreira, Aline dos Santos Silva, Cléber Glória Chang, Junbiao Lei, Pingsheng Front Med (Lausanne) Medicine BACKGROUND: In 2019, a highly pathogenic coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surfaced and resulted in the outbreak of coronavirus disease 2019 (COVID-19). With the aim of finding effective drugs to fight against the disease, several trials have been conducted since COVID-19 can only be considered a treatable disease, from a clinical point of view, after the availability of specific and effective antivirals. AZVUDINE (FNC), initially developed for treating HIV, is a potential treatment for COVID-19 as it has the capability to lower the patient’s viral load and promote recovery. METHODS: Volunteers infected with SARS-CoV-2 confirmed by reverse transcription polymerase chain reaction (RT-PCR), with good kidney and liver function, who were not using other antivirals or monoclonal antibodies were eligible. Samples from patients were assessed for viral load every 48 h during treatment using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and droplet digital polymerase chain reaction (ddPCR). RESULTS: The study’s primary outcome measure was the percentage of participants showing an improvement in clinical scores, while the secondary outcome measure was the percentage of participants with a clinical outcome of cure. These measures were used to assess the safety and efficacy of FNC for treating COVID-19. In the analysis of sociodemographic variables, no significant differences were detected between patients in the FNC and the placebo group for race, age group, or sex. The results showed a potential benefit to participants who received FNC during the study, as observed in the shorter hospital stay, shorter negative conversion time of SARS-CoV-2, and a significant reduction in viral load. Furthermore, the reduction in fever and chills were significant at D1, D2, and D3. In this study, a total of 112 adverse events cases were noted, with 105 cases being categorized as non-serious and only 7 cases as serious adverse events. CONCLUSION: The pandemic is not being effectively controlled and is causing multiple waves of infection that require extensive medical resources. However, FNC has demonstrated potential to reduce the treatment duration of moderate COVID-19 cases, thereby saving significant medical resources. This makes FNC a promising candidate for COVID-19 treatment. Clinical trial registration: [clinicaltrials.gov], identifier [NCT04668235]. Frontiers Media S.A. 2023-10-19 /pmc/articles/PMC10620601/ /pubmed/37928473 http://dx.doi.org/10.3389/fmed.2023.1215916 Text en Copyright © 2023 de Souza, Cabral, da Silva, Arruda, Cabral, de Assis, Viana Junior, Degrave, Moreira, Silva, Chang and Lei. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine de Souza, Sávio Bastos Cabral, Paula Gebe Abreu da Silva, Renato Martins Arruda, Raul Ferraz Cabral, Sheila Passos de Figueiredo de Assis, Arícia Leone Evangelista Monteiro Viana Junior, Antônio Brazil Degrave, Wim Maurits Sylvain Moreira, Aline dos Santos Silva, Cléber Glória Chang, Junbiao Lei, Pingsheng Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title | Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title_full | Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title_fullStr | Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title_full_unstemmed | Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title_short | Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients |
title_sort | phase iii, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of azvudine in moderate covid-19 patients |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10620601/ https://www.ncbi.nlm.nih.gov/pubmed/37928473 http://dx.doi.org/10.3389/fmed.2023.1215916 |
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