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 | Terminated Phase 2 DMC

• 1 other identifier: 2020-002462-14
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19

  Number of patients that a short cycle of steroids (with prednisone 60 mg/d, in a single dose, for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.

  28 days

Secondary Outcomes (3)

• Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment

  28 days

• Percentage of patients who stop medication due to adverse events.

  28 days

• Severity of symptoms by COVID-19 in the two treatment arms

  28 days

Study Arms (2)

colchicine + prednisone

EXPERIMENTAL

Prednisone should be administered for 3 consecutive days (60 mg/d) together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function) for 3 days and maintained for 14 days in total (0.5 mg/d).

Drug: Colchicine; Drug: Prednisone tablet

Standard treatment

ACTIVE COMPARATOR

The standard treatment used in each site will be administered to the patients assigned to the control group.

Drug: standard of care

Interventions

Colchicine DRUG

Colchicine: ideal dose of 0.3 mg/kg/day (or the dose that approximates that adjusted for age, weight and kidney function, and 0.5 mg and 1 mg tablets)

colchicine + prednisone

Prednisone tablet DRUG

Prednisone 60 mg/day, in a single dose, during 3 days

colchicine + prednisone

standard of care DRUG

The standard treatment used in each site will be administered to the patients assigned to the control group.

Standard treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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).
• Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
• Acceptance by the patient or responsible family member to participate in the study (written consent).

You may not qualify if:

• 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).
• 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)
• 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.
• 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).

Sponsors & Collaborators

• Maria Joyera Rodríguez: lead

Study Sites (3)

Centre Blauclínic Dolors Aleu

Barcelona, 08023, Spain

Location

Hospital Clinic, Department of Internal Medicine

Barcelona, 08036, Spain

Location

Clinica Sant Antoni

Barcelona, 08038, Spain

Location

Related Publications (1)

• Hernandez-Rodriguez J, Duran-Sanclemente J, Prieto-Gonzalez S, Araujo O, Hospital-Vidal T, Casanovas G, Sapena V, Blanco JL, Lopez-Soto A; FRAGILE-COLCOVID19 Study Group. FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities. Clin Drug Investig. 2022 Nov;42(11):949-964. doi: 10.1007/s40261-022-01201-2. Epub 2022 Sep 29.

  PMID: 36173596 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine; Prednisone; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: October 22, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

ES (3)