Ensayo clínico aleatorizado para investigar la eficacia de la administración anticipada de la colchicina en pacientes mayores de 70 años y de alto riesgo en tener complicaciones pulmonares como neumonía asociada al coronavirus.
- Conditions
- Adult patients over 70 years of age diagnosed by COVID-19 with outpatient follow-upMedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001603-16-ES
- Lead Sponsor
- IDIVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1024
1. Patients of either sex who are at least 70 years old.
2.Diagnosis of COVID-19 infection within the last 24 hours and confirmed by PCR
3.The patient must be able to read and/or understand the content, read by a third party, of the information collected in the PIH.
4.Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
5.The patient must possess at least two of the following high-risk criteria:
a.70 years of age or older
AND
b.Any of the following: Diabetes mellitus, uncontrolled hypertension (systolic blood pressure =150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the combination of a high neutrophil count and a low lymphocyte count
6.The patient must be able and willing to comply with the requirements of this study protocol.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1024
1. Inpatient or under immediate consideration of doing
2. Patient with an inability to read and/or understand the content, read by a third party, of the information collected in the PIH.
3. Patient in a state of shock or with hemodynamic instability;
4. Patient taking colchicine for other indications
5. Patient with history of allergic reaction or sensitivity to colchicine
6. Patient with severe gastrointestinal disorders such as inflammatory bowel disease, gastric ulcer, chronic diarrhea a or malabsorption
7. Patient with pre-existing progressive neuromuscular disease
8. Patient with renal damage and estimated glomerular filtrate rate <30 ml/m at 1732
9. Patient with a history of cirrhosis, chronic active hepatitis or severe liver disease
10. Patient undergoing chemotherapy for cancer.
11. Patient with hematological disorders, such as blood dyscrasias
12. Patients being treated with CYP3A4 and/or P-glycoprotein inhibitor drugs.
13. If the investigator considers you, for any reason, to be an unsuitable candidate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if early treatment with colchicine reduces the rate of death and serious lung complications related to COVID-19 in patients over 70 years of age with at-risk comorbidities.;Secondary Objective: Not applicable;Primary end point(s): Number of participants who die or require hospitalization due to 19-COVID infection within 30 days of randomization;Timepoint(s) of evaluation of this end point: 1 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Number of participants requiring mechanical ventilation within 30 days of randomization<br>-Number of patients with Adverse Events/Serious Adverse Reactions during treatment;Timepoint(s) of evaluation of this end point: 1 month for the first secondary target and two months for the second secondary target