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

© 2021. The Author(s)..

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:22

Enthalten in:

Trials - 22(2021), 1 vom: 06. Sept., Seite 590

Sprache:

Englisch

Beteiligte Personen:

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

Links:

Volltext

Themen:

Clinical Trial Protocol
Colchicine
Coronavirus
Early treatment
Journal Article
No hospitalized
Primary health care
SML2Y3J35T

Anmerkungen:

Date Completed 08.09.2021

Date Revised 03.04.2024

published: Electronic

ClinicalTrials.gov: NCT04416334

Citation Status MEDLINE

doi:

10.1186/s13063-021-05544-7

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM330312456