Colchicine in COVID-19: a Pilot Study

COVID-19 Clinical Trial

— COLVID-19  

Official title:

Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04375202
• Other study ID #: 2020-001475-33
• Status: Terminated
• Phase: Phase 2
• Start date: April 18, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2022
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.

Description:

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.

One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 227
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent for participation in the study

• Virological diagnosis of SARS-CoV-2 infection (real-time PCR)

• Hospitalized due to clinical/instrumental diagnosis of pneumonia

• Oxygen saturation at rest in ambient air =94%

• PaO2/FiO2 ratio of 350 to 200

Exclusion Criteria:

• Known hypersensitivity to colchicine or its excipients

• Severe diarrhea

• Patients who cannot take oral therapy

• Pregnant and lactating patients

• Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)

• 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.

• Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician

• Neutrophils <1.000 / mmc

• Platelets <50.000 / mmc

• Bowel diverticulitis or perforation

• Patients already in ICU or requiring mechanical ventilation

• Patients receiving Tocilizumab

• Patients already enrolled in other clinical trials

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Colchicine 1 MG Oral Tablet
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.

Locations

Country	Name	City	State
Italy	Associazione Italiana Pneumologi Ospedalieri	Milan
Italy	Società Italiana di Reumatologia	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of entering the critical stage	Comply with any of the followings: Respiratory failure occurs and requires mechanical ventilation; Patients combined with other organ failure need ICU monitoring and treatment; Death	[1 month]
Secondary	Trend of White blood cell count		[up to 30 days]
Secondary	Change of the "Sequential Organ failure Assessment" (SOFA)		[up to 30 days]
Secondary	Rate of biochemical criterion (CK, ALT, ferritin) recovery		[up to 30 days]
Secondary	Rate of disease remission	Comply with any of the followings: No fever, cough and other symptoms; SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation	[up to 30 days]

External Links

•   Related Info