PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS
COLCHI-COVID
1 other identifier
interventional
70
1 country
4
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 of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2022
CompletedNovember 8, 2023
November 1, 2023
1.8 years
June 3, 2020
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants who die due to COVID-19 infection
21 days post-randomization
Number of participants who require hospitalization due to COVID-19 infection
21 days post-randomization
Other Outcomes (1)
A confirmed diagnosis from COVID-19 infection (by positive PCR test) will be mandatory .
48 hours
Study Arms (2)
Colchicine plus symptomatic treatment (paracetamol).
EXPERIMENTALPatients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced. All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.
Symptomatic treatment
ACTIVE COMPARATORSymptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
Interventions
Colchicine plus symptomatic treatment (paracetamol).
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto de Investigación Marqués de Valdecillalead
- Gerencia de atención primaria área 1collaborator
- Gerencia de atención primaria área 2collaborator
- Gerencia Atencion Primaria Area 3collaborator
- Gerencia de atención primaria área 4collaborator
Study Sites (4)
Atención primaria (Área 2)
Laredo, Cantabria, Spain
Gerencia de atención primaria (Área 3)
Reinosa, Cantabria, Spain
Atencion primaria (AREA 1)
Santander, Cantabria, Spain
Gerencia de atención primaria (área 4)
Torrelavega, Cantabria, Spain
Related Publications (1)
Estebanez EB, Alconero LL, Fernandez BJ, Marguello MG, Caro JCL, Vallejo JD, Sampedro MF, Cacho PM, Espiga CR, Saiz MMG. The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study. Trials. 2021 Sep 6;22(1):590. doi: 10.1186/s13063-021-05544-7.
PMID: 34488841DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 4, 2020
Study Start
August 19, 2020
Primary Completion
June 1, 2022
Study Completion
October 11, 2022
Last Updated
November 8, 2023
Record last verified: 2023-11