Clinical trial NCT04375202: Colchicine in COVID-19: a Pilot Study
Official title: Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID
COVID-19
CORONAVIRUS
SARS-COV-2
COLCHICINE
IL-1
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of entering the critical stage
timeFrame: [1 month]
Secondary outcomes:
measure: Trend of White blood cell count
timeFrame: [up to 30 days]
measure: Change of the "Sequential Organ failure Assessment" (SOFA)
timeFrame: [up to 30 days]
measure: Rate of biochemical criterion (CK, ALT, ferritin) recovery
timeFrame: [up to 30 days]
measure: Rate of disease remission
timeFrame: [up to 30 days]
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Associazione Italiana Pneumologi Ospedalieri
city: Milan
country: Italy
facility: Società Italiana di Reumatologia
Study officials:
References:
citation: 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.
citation: Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.