Randomized open-blind controlled trial to study the benefit of Colchicine in Patients with COVID-19

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Immune system processes [G12]; COVID19

• Registration Number: EUCTR2020-001511-25-ES
• Lead Sponsor: FFIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1.Infection confirmed by SARS-CoV-2 by RT-PCR.
2. Hospital admission in the previous 48 hours for clinical involvement in groups 3, 4 or 5 of the WHO clinical scale.
3. Age over 18 years.
4. Granting of informed consent in writing.
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 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

1. Need for invasive ventilatory support
2. Limitation of therapeutic effort due to poor vital prognosis
3. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption.
4. Previous neuromuscular disease
5. Different disease with estimated life prognosis less than 1 year.
6. Severe kidney failure (glomerular filtration rate <30 mL / m in / 1.73m2)
7. History of cirrhosis, active chronic hepatitis, or severe liver disease defined by GOT (AST) or GPT (ALT) values ??that exceed 3 x upper limit of normality
8. Patient who is taking colchicine for other indications (mainly chronic prescriptions for family Mediterranean fever or gout) (No washout period will be required for patients who have been treated with colchicine and have stopped treatment before randomization).
9. Patient with a history of allergic reactions or significant sensitivity to colchicine.
10. Treatment with immunosoppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
11. Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive result in the analysis of human chorionic gonadotropin (hCG).
12. Fertile, or postmenopausal female patient less than 1 year old, and not surgically sterilized. Women of childbearing potential who are using at least one contraceptive method and preferably two complementary methods of contraception, including a barrier method (male or female condoms, spermicides, sponges, foams, contraceptive gels, diaphragms, intrauterine device) may be included throughout the entire study and up to 30 days after the end of the study.
13. Use of other investigational drugs at the time of enrollment, or during the 30 days prior to enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified