Status:
COMPLETED
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Collaborating Sponsors:
Gerencia de atención primaria área 1
Gerencia de atención primaria área 2
Conditions:
SARS-CoV-2 Infection (COVID-19)
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk ...
Detailed Description
The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with ...
Eligibility Criteria
Inclusion
- Patients of both sexes who are at least 60 years old.
- Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
- Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
- The patient must possess at least two of the following high-risk criteria
- 60 years of age or older AND
- Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia
- The patient must be able and willing to comply with the requirements of this study protocol.
Exclusion
- Hospitalized patient or under immediate consideration of doing so
- Patient taking colchicine for other indications
- Patient with history of allergic reaction or sensitivity to colchicine
- Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
- Patient with pre-existing progressive neuromuscular disease
- Patient with kidney damage and estimated glomerular filtrate rate \<30 ml/m at 1732
- Patient undergoing chemotherapy for cancer, including haematological malignancies.
- Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
- Immunosuppressive treatment
- History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
- If the investigator considers it, for any reason, to be an inadequate candidate.
- Patient and/or legal representative will not have signed the informed consent form.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04416334
Start Date
August 19 2020
End Date
October 11 2022
Last Update
November 8 2023
Active Locations (4)
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1
Atención primaria (Área 2)
Laredo, Cantabria, Spain
2
Gerencia de atención primaria (Área 3)
Reinosa, Cantabria, Spain
3
Atencion primaria (AREA 1)
Santander, Cantabria, Spain
4
Gerencia de atención primaria (área 4)
Torrelavega, Cantabria, Spain