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Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial
OBJECTIVES: The COVID-19 pandemic has revealed a severe need for effective antiviral treatment. The objectives of this study were to assess if preemptive treatment with amantadine for COVID-19 in non-hospitalized persons ≥40 years or adults with comorbidities was able to prevent disease progression...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10284620/ https://www.ncbi.nlm.nih.gov/pubmed/37353078 http://dx.doi.org/10.1016/j.cmi.2023.06.023 |
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author | Weis, Nina Bollerup, Signe Sund, Jon Dissing Glamann, Jakob Borg Vinten, Caroline Jensen, Louise Riger Sejling, Christoffer Kledal, Thomas Nitschke Rosenkilde, Mette Marie |
author_facet | Weis, Nina Bollerup, Signe Sund, Jon Dissing Glamann, Jakob Borg Vinten, Caroline Jensen, Louise Riger Sejling, Christoffer Kledal, Thomas Nitschke Rosenkilde, Mette Marie |
author_sort | Weis, Nina |
collection | PubMed |
description | OBJECTIVES: The COVID-19 pandemic has revealed a severe need for effective antiviral treatment. The objectives of this study were to assess if preemptive treatment with amantadine for COVID-19 in non-hospitalized persons ≥40 years or adults with comorbidities was able to prevent disease progression and hospitalization. Primary outcomes were clinical status on day 14. METHODS: Between 9(th) June 2021 and 27(th) January 2022, this randomized, double-blinded, placebo-controlled, single-center clinical trial included 242 subjects with a follow-up period of 90 days. Subjects were randomized 1:1 to either amantadine 100 mg or placebo twice daily for five days. The inclusion criteria were confirmed SARS-CoV-2 infection and at least one of (i) age ≥ 40 years, age ≥ 18 years (ii) and at least one comorbidity, or - (iii) and BMI ≥ 30. The study protocol was published at www.clinicaltrials.gov (unique protocol #02032021) and at www.clinicaltrialregister.eu (EudraCT-number 2021-001177-22). RESULTS: With 121 participants in each arm, we found no difference in the primary endpoint with 82 participants in the amantadine arm, and 92 participants in the placebo arm with no limitations to activities, respectively, and 25 and 37 with limitations to activities in the amantadine arm and the placebo arm respectively. No participants in either group were admitted to hospital or died. The Odds Ratio of having state severity increased by 1 in the amantadine group versus placebo was 1.8 (Confidence Interval 1.0-3.3, (p=0.051)). At day 7, one participant was hospitalized in each group; throughout the study this increased to five and three participants for amantadine versus placebo treatment (P=0.72). Similarly, at day 7, there was no difference in the status of oropharyngeal swabs. Most participants (108 in each group) were SARS-CoV-2 RNA positive (p=0.84). CONCLUSIONS: We found no effect of amantadine on disease progression of SARS-CoV-2 infection. |
format | Online Article Text |
id | pubmed-10284620 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102846202023-06-22 Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial Weis, Nina Bollerup, Signe Sund, Jon Dissing Glamann, Jakob Borg Vinten, Caroline Jensen, Louise Riger Sejling, Christoffer Kledal, Thomas Nitschke Rosenkilde, Mette Marie Clin Microbiol Infect Original Article OBJECTIVES: The COVID-19 pandemic has revealed a severe need for effective antiviral treatment. The objectives of this study were to assess if preemptive treatment with amantadine for COVID-19 in non-hospitalized persons ≥40 years or adults with comorbidities was able to prevent disease progression and hospitalization. Primary outcomes were clinical status on day 14. METHODS: Between 9(th) June 2021 and 27(th) January 2022, this randomized, double-blinded, placebo-controlled, single-center clinical trial included 242 subjects with a follow-up period of 90 days. Subjects were randomized 1:1 to either amantadine 100 mg or placebo twice daily for five days. The inclusion criteria were confirmed SARS-CoV-2 infection and at least one of (i) age ≥ 40 years, age ≥ 18 years (ii) and at least one comorbidity, or - (iii) and BMI ≥ 30. The study protocol was published at www.clinicaltrials.gov (unique protocol #02032021) and at www.clinicaltrialregister.eu (EudraCT-number 2021-001177-22). RESULTS: With 121 participants in each arm, we found no difference in the primary endpoint with 82 participants in the amantadine arm, and 92 participants in the placebo arm with no limitations to activities, respectively, and 25 and 37 with limitations to activities in the amantadine arm and the placebo arm respectively. No participants in either group were admitted to hospital or died. The Odds Ratio of having state severity increased by 1 in the amantadine group versus placebo was 1.8 (Confidence Interval 1.0-3.3, (p=0.051)). At day 7, one participant was hospitalized in each group; throughout the study this increased to five and three participants for amantadine versus placebo treatment (P=0.72). Similarly, at day 7, there was no difference in the status of oropharyngeal swabs. Most participants (108 in each group) were SARS-CoV-2 RNA positive (p=0.84). CONCLUSIONS: We found no effect of amantadine on disease progression of SARS-CoV-2 infection. The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. 2023-06-22 /pmc/articles/PMC10284620/ /pubmed/37353078 http://dx.doi.org/10.1016/j.cmi.2023.06.023 Text en © 2023 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Original Article Weis, Nina Bollerup, Signe Sund, Jon Dissing Glamann, Jakob Borg Vinten, Caroline Jensen, Louise Riger Sejling, Christoffer Kledal, Thomas Nitschke Rosenkilde, Mette Marie Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title | Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title_full | Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title_fullStr | Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title_full_unstemmed | Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title_short | Amantadine for COVID-19 treatment (ACT study): a randomized, double-blinded, placebo-controlled clinical trial |
title_sort | amantadine for covid-19 treatment (act study): a randomized, double-blinded, placebo-controlled clinical trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10284620/ https://www.ncbi.nlm.nih.gov/pubmed/37353078 http://dx.doi.org/10.1016/j.cmi.2023.06.023 |
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