Evaluation of the colchicine tablet efficacy as an adjuvant therapy for patients with mild to moderate COVID-19

Phase 3

Recruiting

Conditions: COVID-19 pneumonia.
COVID-19, virus identified
U07.1

Registration Number: IRCT20200408046990N2

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Clinical or laboratory diagnosis of mild to moderate covid-19
age between 18-85 y
sign of written consent

Exclusion Criteria

use of protease inhibitors like kaletra
history of allergy to colchicine
pregnancy and lactation
hepatic failure (child pugh C), kidney failure (GFR<30 ml/min), or heart failure with EF<40%
concomitant use of CYP3A4 or pgp potent inhibitors or inducers
concomitant use of statins except rosuvastatin
active GI disturbances like active peptic ulcers
transmission of patients to ICU ward or his/her intubation
patients on colchicine for behcet disease or Mediterranean fever or gout
patients with history of neuromuscular disease or chronic diarrhea or malabsorption

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fever. Timepoint: daily. Method of measurement: thermometer.;Clinical response to treatment (including improvement of cough, myalgia, headache, Olfactory and taste disorders). Timepoint: daily. Method of measurement: Based on patients examination and interview.;Radiologic response. Timepoint: two weeks after treatment. Method of measurement: lung CT scan.;Laboratory response. Timepoint: weekly. Method of measurement: assessment of serum level of CRP and CBC diff.;Drug adverse reaction. Timepoint: daily. Method of measurement: patient file and interview.

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization. Timepoint: end of the treatment. Method of measurement: patients' file.;Patients' clinical outcome. Timepoint: at the of the treatment. Method of measurement: patients' file.