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TERMINATEDPHASE2/PHASE3

Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

NCT04492358•Maria Joyera Rodríguez

View on ClinicalTrials.gov

Summary

Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center
•2. Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context), with a disease considered moderate (grade 3-4) or severe (grade 5) according to the WHO 8-point ordinal scale for assessing clinical severity (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis). This same scale will also be used to evaluate the evolution after the application of the corresponding treatment. Baseline clinical parameters will include the presentation of fever and any respiratory symptoms, both of upper respiratory tract and dyspnea, affecting the general state or gastrointestinal manifestations, since it is known that in elderly people the COVID-19 can present with atypical symptoms for a time that is difficult to determine, but it also tends to evolve to respiratory failure quickly and is associated with high mortality. For this reason, regardless of the time that has elapsed since the estimated onset of symptoms, patients with moderate - WHO grade 3, in whom the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to COVID-19 make an admission (in the case of hospital) and directed treatment (in all cases) advisable, will be candidates for inclusion in the study. Patients with moderate disease and oxygen requirements (WHO grade 4) and patients with severe pneumonia, but who can be managed initially with high flow oxygen therapy (WHO grade 5) may also be included in the study. The clinical diagnosis may be supported by radiological changes (via chest radiography, if available) suggestive of bilateral (established or incipient) pneumonia. At the time of diagnosis, biomarkers will also be collected, in an analysis that will include increased levels of C-reactive protein \[PCR\] and/or ferritin and microbiological confirmation of SARS-CoV-2.
•3. Patients in whom the current clinical situation and the basal functional situation condition a prognosis that makes them consider a limited therapeutic ceiling, which includes the contraindication of applying more aggressive (e.g. non-invasive ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal intubation and mechanical ventilation), both in patients admitted to the Geriatric Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care center. The latter patients are also not considered for transfer to a third level hospital (according to the criteria of fragility, available on page 14 of the CatSalut action protocols (https://canalsalut.gencat.cat/web/.content/\_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
•4. Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
•5. Acceptance by the patient or responsible family member to participate in the study (written consent).

Exclusion Criteria

•1. The clinical situation of an advanced or terminal illness, according to the clinical judgment of the doctor in charge and as defined by the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced illness in an evolutionary and irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with very little or no capacity to respond to specific treatment and with a life expectancy limited to weeks or months, in a context of progressive fragility (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
•2. Clinical status which is advanced and severe or in which the level of consciousness has deteriorated and the oral route of taking the medication is not safely tolerated (in the opinion of the doctor in charge)
•3. Taking any of the drugs in the trial (colchicine or prednisone) chronically or intermittently in the 7 days prior to study inclusion.
•4. Absolute contraindication to the use of the study medication, including hypersensitivity to the active substance or to any of its excipients, severe renal failure (glomerular filtration \[GF\] creatinine clearance or Clcr \<30 ml/min) and patients undergoing haemodialysis, severe liver failure, severe gastrointestinal disorders, gastric ulcer or blood dyscrasias.
•5. Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir), all potent inhibitors of CYP3A4 (key cytochrome in the colchicine metabolism pathway).

Locations (3)

Centre Blauclínic Dolors Aleu

Barcelona, Spain

Hospital Clinic, Department of Internal Medicine

Barcelona, Spain

Clinica Sant Antoni

Barcelona, Spain

Key Dates

Start Date

October 22, 2020

Primary Completion Date

May 31, 2021

Completion Date

May 31, 2021

Last Updated

February 21, 2023

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

Colchicine

DRUG

Prednisone tablet

DRUG

standard of care

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

Inclusion Criteria

Exclusion Criteria

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