Infection by COVID19 MedDRA version: 28.0 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Colchicina Seid
Pharmaceutical Form: Tablet
INN or Proposed INN: Colchicina
CAS Number: 64-86-8
Other descriptive name: COLCHICINE
Concentration unit: mg milligram(s)
Concentration type: r
Sponsors
Fundació Clinic per a la Recerca Biomèdica (FCRB)
Eligibility
Sex/Gender
All
Inclusion criteria
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 an illness considered moderate (grade 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 applying 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 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 elapsed since the estimated onset of symptoms, patients with moderate disease with oxigen requirements grade 4 of the WHO, in which the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to the COVID-19, make an admission (in case of hospital) and a directed treatment (in all cases) are candidates to be included in the study. 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 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 therapy, 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: 1. Clinical situation of advanced basic disease or terminal illness in the clinical judgement of the responsible physician and according to the definition of the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced disease 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 prognosis 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 (FG <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, azithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether treatment with a short cycle of steroids (with prednisone 60 mg/d 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.;Secondary Objective: 1. To assess and compare the safety of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment according to the incidence of: - Mild adverse events -Serious adverse events - Hypersensitivity (allergic) reactions of grade = 2. -Clinically significant invasive bacterial or fungal infections 2. Percentage of patients who stop medication due to adverse events. 3. Assess and compare the duration and severity of symptoms by COVID-19 in the two treatment arms (response to treatment to be assessed by overall survival at 28 days from the start of treatment).;Primary end point(s): Ratio of patients who die within 28 days of the start of treatment.;Timepoint(s) of evaluation of this end point: 28 days of the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary safety assessment criteria in both groups: -Percentage of patients who develop mild adverse events (e.g., diarrhea, abdominal pain, mild nausea and vomiting, as the most frequent and expected) and/or serious adverse events (any new events accompanying the previous ones, not attributable to COVID-19). - Ratio of patients who develop an allergy attributable to treatment. - Ratio of patients who develop a bacterial or fungal infection during treatment - Ratio of patients who drop out of treatment due to adverse effects. Secondary endpoints related to disease progression in both groups -Improvement in the WHO 8-point scale (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis) - The time until resolution of the initial clinical event, maintained for at least 72 hours - Percentage of patients who worsen (e.g., development of dyspnea or worsening of basal dyspnea) during treatment - Leukocyte count, hemoglobin, platelets, creatinine, total bilirubin, alanine aminotransferase (ALT), at baseline, between days 10-20 and 28 (if still admitted) - Mortality from any cause.;Timepoint(s) of evaluation of this end point: 28 days of the start of treatment | — |
Countries
Spain
Contacts
Public ContactMaria Joyera
CTU Clinic
Outcome results
None listed