The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study
Abstract Background There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first leve...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05544-7 |
| _version_ | 1819129347600023552 |
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| author | Elena Bustamante Estebanez Lucía Lavín Alconero Beatriz Josa Fernández Monica Gozalo Marguello Juan Carlos López Caro Jonathan Diez Vallejo Marta Fernandez Sampedro Pedro Muñoz Cacho Carlos Richard Espiga María Mar García Saiz |
| author_facet | Elena Bustamante Estebanez Lucía Lavín Alconero Beatriz Josa Fernández Monica Gozalo Marguello Juan Carlos López Caro Jonathan Diez Vallejo Marta Fernandez Sampedro Pedro Muñoz Cacho Carlos Richard Espiga María Mar García Saiz |
| author_sort | Elena Bustamante Estebanez |
| collection | DOAJ |
| description | Abstract Background There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. Methods The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. Discussion This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. Trial registration ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020. |
| first_indexed | 2024-12-22T08:42:17Z |
| format | Article |
| id | doaj.art-6486479d2d3848e6a70223b270209caa |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T08:42:17Z |
| publishDate | 2021-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6486479d2d3848e6a70223b270209caa2022-12-21T18:32:12ZengBMCTrials1745-62152021-09-0122111210.1186/s13063-021-05544-7The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID studyElena Bustamante Estebanez0Lucía Lavín Alconero1Beatriz Josa Fernández2Monica Gozalo Marguello3Juan Carlos López Caro4Jonathan Diez Vallejo5Marta Fernandez Sampedro6Pedro Muñoz Cacho7Carlos Richard Espiga8María Mar García Saiz9Management of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de SaludMarqués de Valdecilla Research Institute (IDIVAL)Management of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de SaludMarqués de Valdecilla Research Institute (IDIVAL)Management of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de SaludManagement of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de SaludMarqués de Valdecilla Research Institute (IDIVAL)Marqués de Valdecilla Research Institute (IDIVAL)Marqués de Valdecilla Research Institute (IDIVAL)Marqués de Valdecilla Research Institute (IDIVAL)Abstract Background There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. Methods The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. Discussion This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. Trial registration ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.https://doi.org/10.1186/s13063-021-05544-7CoronavirusColchicinePrimary health careEarly treatmentNo hospitalized |
| spellingShingle | Elena Bustamante Estebanez Lucía Lavín Alconero Beatriz Josa Fernández Monica Gozalo Marguello Juan Carlos López Caro Jonathan Diez Vallejo Marta Fernandez Sampedro Pedro Muñoz Cacho Carlos Richard Espiga María Mar García Saiz The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study Trials Coronavirus Colchicine Primary health care Early treatment No hospitalized |
| title | The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study |
| title_full | The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study |
| title_fullStr | The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study |
| title_full_unstemmed | The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study |
| title_short | The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study |
| title_sort | effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia sars cov 2 covid 19 study protocol for an investigator driven randomized controlled clinical trial in primary health care colchicovid study |
| topic | Coronavirus Colchicine Primary health care Early treatment No hospitalized |
| url | https://doi.org/10.1186/s13063-021-05544-7 |
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