Clinical trial NCT04416334: PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS
Official title: PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection (COVID-19)
Keywords: colchicine
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
Collaborators: name: Gerencia de atención primaria área 1
name: Gerencia de atención primaria área 2
name: Gerencia Atencion Primaria Area 3
name: Gerencia de atención primaria área 4
First posted: 2020-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 comorbidities.

The secondary objective is to determine the safety of colchicines in this patient population.

Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes who are at least 60 years old.
2. Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
3. Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
4. The patient must possess at least two of the following high-risk criteria

   1. 60 years of age or older AND
   2. 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
5. The patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Hospitalized patient or under immediate consideration of doing so
2. Patient taking colchicine for other indications
3. Patient with history of allergic reaction or sensitivity to colchicine
4. Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
5. Patient with pre-existing progressive neuromuscular disease
6. Patient with kidney damage and estimated glomerular filtrate rate \<30 ml/m at 1732
7. Patient undergoing chemotherapy for cancer, including haematological malignancies.
8. Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
9. Immunosuppressive treatment
10. History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
11. If the investigator considers it, for any reason, to be an inadequate candidate.
12. Patient and/or legal representative will not have signed the informed consent form.

Primary outcomes:
measure: Number of participants who die due to COVID-19 infection
timeFrame: 21 days post-randomization
measure: Number of participants who require hospitalization due to COVID-19 infection
timeFrame: 21 days post-randomization
Secondary outcomes:
Other outcomes:
measure: A confirmed diagnosis from COVID-19 infection (by positive PCR test) will be mandatory .
timeFrame: 48 hours
Locations:
city: Laredo
country: Spain
facility: Atención primaria (Área 2)
state: Cantabria
city: Reinosa
country: Spain
facility: Gerencia de atención primaria (Área 3)
state: Cantabria
city: Santander
country: Spain
facility: Atencion primaria (AREA 1)
state: Cantabria
city: Torrelavega
country: Spain
facility: Gerencia de atención primaria (área 4)
state: Cantabria
Study officials:
References:
citation: 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.