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1. 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

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, and María Mar García Saiz

Subjects
Coronavirus, Colchicine, Primary health care, Early treatment, No hospitalized, Medicine (General), R5-920
Abstract

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.

Published
2021
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2. 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

Author

Carlos Richard Espiga, Pedro Muñoz Cacho, Jonathan Diez Vallejo, Juan Carlos López Caro, Elena Bustamante Estebanez, Marta Fernandez Sampedro, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, and María Mar García Saiz

Subjects
Medicine (General), medicine.medical_specialty, Population, Medicine (miscellaneous), Disease, medicine.disease_cause, chemistry.chemical_compound, Study Protocol, R5-920, Internal medicine, Early treatment, Pandemic, Medicine, Colchicine, Humans, Multicenter Studies as Topic, Pharmacology (medical), education, Pandemics, Coronavirus, Aged, Randomized Controlled Trials as Topic, education.field_of_study, Primary Health Care, business.industry, SARS-CoV-2, COVID-19, Middle Aged, medicine.disease, Clinical trial, No hospitalized, Pneumonia, Clinical research, Treatment Outcome, chemistry, business
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.govNCT04416334. Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.

Published
2021

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