Status:
COMPLETED
Trial to Study the Benefit of Colchicine in Patients With COVID-19
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity attributed to the i...
Detailed Description
This is a Phase III, prospective, pragmatic, randomized, controlled and open-label trial, comparing standard of care vs. standard of care plus COLCHICINE for four weeks, in patients hospitalized due t...
Eligibility Criteria
Inclusion
- SARS-CoV-2 infection confirmed by PCR.
- Admitted in the hospital in the previous 48 hours, with clinical status 3, 4 or 5 of WHO classification.
- Age above 18 years old.
- Informed written consent.
Exclusion
- Invasive mechanical ventilation needed.
- Established limitation of the therapeutic effort
- Inflammatory bowel disease (IBD: Chron Syndrome or Ulcerative colitis), chronic diarrhea or malabsorption.
- Previous neuromuscular disease.
- Other disease with an estimated vital prognosis under 1 year.
- Severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2)
- Medical records of cirrhosis, active chronic hepatitis or severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit.
- Patients with previous colchicine treatment for other diseases (mainly chronic prescriptions for familial Mediterranean fever or gout). Clearance period will not be required for patients treated with colchicine who stopped the treatment before the randomization.
- Patients with history of allergic reaction or significant sensitivity to colchicine.
- Treatment with immunosuppressive agents, corticoids or interleukine-1 antagonists for 6 months before inclusion.
- Pregnant or breastfeeding female, confirmed by a positive result in the human chorionic gonadotropin (hCG) test.
- Fertile woman, or post-menopausal during less than one year and non-surgically sterilized. Women of fertile age may be included if using at least one contraceptive method and preferably two complementary contraceptive methods.
- Use of other investigational drugs in the moment of inclusion, or during 30 days previous to inclusion.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04350320
Start Date
April 30 2020
End Date
December 30 2020
Last Update
January 12 2021
Active Locations (1)
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1
Virgen de la Arrixaca University Clinical Hospital
Murcia, Spain, 30120