A study using colchicine for preventing the complications from Covid-19
- Conditions
- This trial will investigate if colchicine could potentially have an effect in patients’ clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001455-40-GR
- Lead Sponsor
- Hellenic Society of Rhythmology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical status that involves body temperature >37.5 oC
AND
2. at least two out of the:
i. sustained coughing,
ii. sustained throat pain,
iii. anosmia and/or ageusia,
iv. fatigue/tiredness,
v. PaO2<95 mmHg.
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126
1. Pregnancy, breastfeeding, or unwillingness to take effective contraceptive methods in men and women of reproductive ability during the clinical trial
2. Hypersensitivity in Colchicine or in any of the excipients of the product (lactose, gum arabic, sucrose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, methylene casein, erythrosine lacquer).
3. Serious hepatic failure
4. eGFR<20 ml/min/1.73m2
5. Clinical estimation that the patient will require mechanical respiratory support in less than 24 hours.
6. Any clinical estimation of the attending physician under which the patient shall be excluded
7. QTc > 450 msec.
8. Participation in a clinical trial with a research product (medication or device) or intervention.
9. Being treated with colchicine for other indications.
10. A person who, at the discretion of the Researcher, is unable to comply with or participate in the clinical trial may place it at unacceptable health risks.
11. A person undergoing haemodialysis
12. Severe gastrointestinal failure, severe gastrointestinal disorder, or stomach ulcer
13. Hematological disorders, such as blood disease
14. Under treatment or 14 days after use of P-glycoprotein inhibitors or CYP3A4 enzyme inhibitors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to address the question whether colchicine, administered in a relatively low dose, could potentially have an effect the patients’ clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.;Secondary Objective: Not applicable;Primary end point(s): Biochemical Phase:<br>1. Difference in maximum high-sensitivity troponin (hs-cTn) within 10 days from treatment initiation<br>2. Time for CRP levels that exceeds > 3xUNL<br><br>Clinical Phase:<br>1. Time to clinical deterioration (criterion: 2 levels in WHO R&D Blueprint scale);Timepoint(s) of evaluation of this end point: 1 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Biochemical Phase:<br>1. The number, the type, the severity and the seriousness of Adverse Events (AE) and the AE related to therapy until the end of monitoring.<br><br>Clinical Phase:<br>1. Percentage of patients who will require mechanical ventilation in every visit<br>2. Mortality by any cause at the end of monitoring<br>3. The number, the type, the severity and the seriousness of Adverse Events (AE) and the AE related to therapy until the end of monitoring.<br>4. Function Lung Tests in healed patients<br>;Timepoint(s) of evaluation of this end point: 2 months