Colchicine in COVID-19: a Pilot Study (COLVID-19)

  • STATUS
    Recruiting
  • participants needed
    308
  • sponsor
    University Of Perugia
Updated on 7 December 2022
pneumonia
mechanical ventilation
FIO2
respiratory failure
pao2
covid-19
pao2/fio2 ratio
SARS
organ failure
oximetry
colchicine

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.

Details
Condition COVID-19
Treatment Colchicine 1 MG Oral Tablet
Clinical Study IdentifierNCT04375202
SponsorUniversity Of Perugia
Last Modified on7 December 2022

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