A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection
IntroductionL-carnitine (LC) has been associated with inflammatory mediator reduction and with downregulating the angiotensin-converting enzyme-2 (ACE2) receptor, which is the target of SARS-CoV-2 attachment.MethodsThis pilot phase 2 randomized, double-blind placebo-controlled trial contained two co...
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Nutrition |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnut.2023.1134162/full |
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| author | Roberto Badaro Josiane Dantas Viana Barbosa Cesar Augusto de Araujo Neto Cesar Augusto de Araujo Neto Bruna Aparecida Souza Machado Milena Botelho Pereira Soares Milena Botelho Pereira Soares Valter de Senna Marcelo Taddeo Marcelo Taddeo Lila Teixeira de Araújo Shane Durkee Raymond Donninger Kevin Judge Zainulabedin Saiyed |
| author_facet | Roberto Badaro Josiane Dantas Viana Barbosa Cesar Augusto de Araujo Neto Cesar Augusto de Araujo Neto Bruna Aparecida Souza Machado Milena Botelho Pereira Soares Milena Botelho Pereira Soares Valter de Senna Marcelo Taddeo Marcelo Taddeo Lila Teixeira de Araújo Shane Durkee Raymond Donninger Kevin Judge Zainulabedin Saiyed |
| author_sort | Roberto Badaro |
| collection | DOAJ |
| description | IntroductionL-carnitine (LC) has been associated with inflammatory mediator reduction and with downregulating the angiotensin-converting enzyme-2 (ACE2) receptor, which is the target of SARS-CoV-2 attachment.MethodsThis pilot phase 2 randomized, double-blind placebo-controlled trial contained two cohorts. Cohort 1 comprised 101 individuals with negative RT-PCR SARS-CoV-2 test results who cohabitated with an individual diagnosed with SARS-CoV-2 infection. Cohort 2 comprised 122 individuals with positive SARS-CoV-2 RT-PCR test results who were asymptomatic or had mild COVID-19 pneumonia symptoms. Participants in each cohort were randomized 1:1 to receive either 2 g elemental oral LC supplementation or placebo daily for 21 days. Primary endpoints included adverse events, SARS-CoV-2 infection incidence in Cohort 1, and disease progressions in Cohort 2. Secondary endpoints included between-group laboratory profile comparisons and Cohort 2 ACE1/ACE2 plasma levels. Disease progression was compared between the Cohort 2 groups using chest computed tomography.ResultsIn Cohort 1, two SARS-CoV-2 infections occurred in each group. The common adverse events included headache, dyspnea, and tiredness. In Cohort 2, platelet counts were elevated, and fibrinogen levels reduced in the LC group compared with those of the placebo group.ConclusionOur study showed that LC was well-tolerated and suggests it modulates coagulation pathways. Furthermore, chest computed tomography images of the Cohort 2 LC group showed significant lung lesion improvement, suggesting that LC may slow COVID-19 progression. |
| first_indexed | 2024-03-12T22:44:52Z |
| format | Article |
| id | doaj.art-15b36a58b68c47ffb90597eabf9ad6e6 |
| institution | Directory Open Access Journal |
| issn | 2296-861X |
| language | English |
| last_indexed | 2024-03-12T22:44:52Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Nutrition |
| spelling | doaj.art-15b36a58b68c47ffb90597eabf9ad6e62023-07-21T07:57:58ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-07-011010.3389/fnut.2023.11341621134162A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infectionRoberto Badaro0Josiane Dantas Viana Barbosa1Cesar Augusto de Araujo Neto2Cesar Augusto de Araujo Neto3Bruna Aparecida Souza Machado4Milena Botelho Pereira Soares5Milena Botelho Pereira Soares6Valter de Senna7Marcelo Taddeo8Marcelo Taddeo9Lila Teixeira de Araújo10Shane Durkee11Raymond Donninger12Kevin Judge13Zainulabedin Saiyed14Institute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilImage Diagnosis, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilGonçalo Moniz Institute, FIOCRUZ, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilFederal University of Bahia, Salvador, Bahia, BrazilInstitute of Health Technologies (ITS), University Center SENAI/CIMATEC, Salvador, Bahia, BrazilResearch and Development, Lonza Greenwood, LLC, Greenwood, SC, United StatesResearch and Development, Lonza Biologics, Slough, United KingdomResearch and Development, Lonza Greenwood, LLC, Greenwood, SC, United StatesResearch and Development, Lonza Greenwood, LLC, Greenwood, SC, United StatesIntroductionL-carnitine (LC) has been associated with inflammatory mediator reduction and with downregulating the angiotensin-converting enzyme-2 (ACE2) receptor, which is the target of SARS-CoV-2 attachment.MethodsThis pilot phase 2 randomized, double-blind placebo-controlled trial contained two cohorts. Cohort 1 comprised 101 individuals with negative RT-PCR SARS-CoV-2 test results who cohabitated with an individual diagnosed with SARS-CoV-2 infection. Cohort 2 comprised 122 individuals with positive SARS-CoV-2 RT-PCR test results who were asymptomatic or had mild COVID-19 pneumonia symptoms. Participants in each cohort were randomized 1:1 to receive either 2 g elemental oral LC supplementation or placebo daily for 21 days. Primary endpoints included adverse events, SARS-CoV-2 infection incidence in Cohort 1, and disease progressions in Cohort 2. Secondary endpoints included between-group laboratory profile comparisons and Cohort 2 ACE1/ACE2 plasma levels. Disease progression was compared between the Cohort 2 groups using chest computed tomography.ResultsIn Cohort 1, two SARS-CoV-2 infections occurred in each group. The common adverse events included headache, dyspnea, and tiredness. In Cohort 2, platelet counts were elevated, and fibrinogen levels reduced in the LC group compared with those of the placebo group.ConclusionOur study showed that LC was well-tolerated and suggests it modulates coagulation pathways. Furthermore, chest computed tomography images of the Cohort 2 LC group showed significant lung lesion improvement, suggesting that LC may slow COVID-19 progression.https://www.frontiersin.org/articles/10.3389/fnut.2023.1134162/fullL-carnitineCOVID-19SARS-CoV-2pneumoniainfection |
| spellingShingle | Roberto Badaro Josiane Dantas Viana Barbosa Cesar Augusto de Araujo Neto Cesar Augusto de Araujo Neto Bruna Aparecida Souza Machado Milena Botelho Pereira Soares Milena Botelho Pereira Soares Valter de Senna Marcelo Taddeo Marcelo Taddeo Lila Teixeira de Araújo Shane Durkee Raymond Donninger Kevin Judge Zainulabedin Saiyed A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection Frontiers in Nutrition L-carnitine COVID-19 SARS-CoV-2 pneumonia infection |
| title | A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection |
| title_full | A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection |
| title_fullStr | A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection |
| title_full_unstemmed | A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection |
| title_short | A randomized clinical trial to evaluate the efficacy of L-carnitine L-tartrate to modulate the effects of SARS-CoV-2 infection |
| title_sort | randomized clinical trial to evaluate the efficacy of l carnitine l tartrate to modulate the effects of sars cov 2 infection |
| topic | L-carnitine COVID-19 SARS-CoV-2 pneumonia infection |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2023.1134162/full |
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