Treatment with COLchicine of patients affected by coronavirus disease (COVID-19): a Pilot Study
- Conditions
- Study population: patients with COVID-19 pneumonia with oxygen saturation deficiency and requiring hospitalization assistance.MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001475-33-IT
- Lead Sponsor
- DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 308
1.Any gender
2.>=18 years old
3.Informed consent for participation in the study
4.Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
5.Hospitalized due to clinical/instrumental diagnosis of pneumonia
6.Oxygen saturation at rest in ambient air =94%
7.PaO2/FiO2 ratio of 350 to 200
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 215
1.Known hypersensitivity to colchicine or its excipients
2.Severe diarrhea
3.Patients who cannot take oral therapy
4.Pregnant and lactating patients
5.Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL
/ min)
6.Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
7.Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
8.Neutrophils <1.000 / mmc
9.Platelets <50.000 / mmc
10.Bowel diverticulitis or perforation
11.Patients already in ICU or requiring mechanical ventilation
12.Patients receiving Tocilizumab
13.Patients already enrolled in other clinical trials
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is the one-month clinical worsening rate understood as a) respiratory failure that requires mechanical ventilation, b) the need for monitoring and treatment in intensive care for organ failure; c) mortality.;Secondary Objective: 1.White blood cell count trend<br>2.Modification of the SOFA score<br>3.Recovery rate of biochemical parameters (CK, ALT, ferritin)<br>4.Disease remission rate<br>5.Toxicity of colchicine;Primary end point(s): One-month clinical worsening rate understood as a) respiratory failure that requires mechanical ventilation, b) the need for monitoring and treatment in intensive care for organ failure; c) mortality.;Timepoint(s) of evaluation of this end point: 30 DAYS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.White blood cell count trend<br>2.Modification of the SOFA score<br>3.Recovery rate of biochemical parameters (CK, ALT, ferritin)<br>4.Disease remission rate<br>5.Toxicity of colchicine;Timepoint(s) of evaluation of this end point: 30 DAYS