Effect of colchicine in treatment of COVID-19

Phase 3

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

Registration Number: IRCT20190810044500N5

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 200

Inclusion Criteria

Age 18 to 70 years
- Detection of COVID-19 in the last 24 to 48 hours
- Candidate for hospitalization (o2sat <93% or RR> 24 or Pao2 / Fio2 <300)
- COVID-19 patients hospitalized with hospital indications according to the guideline of the country that has pulmonary infiltration in CT scan
-Not being pregnant and not becoming pregnant until 30 days after the end of the study
- No consumption of colchicine during the last week ( due to the half-life of 20-40 hours of the drug)
- Outpatients with pulmonary infiltration on CT scan

Exclusion Criteria

Patients with a history of Crohn or Ulcerative colitis, diarrhea, or chronic malabsorption
Neuromuscular diseases
GFR less than 30 ml per minute
History of cirrhosis, hepatitis and severe liver disease
Patients receiving chemotherapy for cancer
Patients currently taking colchicine for other uses, such as gout or Mediterranean fever
Patients with a history of allergic reactions or allergies to colchicine
Pregnancy and lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Clinical symptoms including fever, cough, shortness of breath. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire.;Pulmonary infiltration findings on CT scan. Timepoint: Two weeks later and 6-8 weeks later. Method of measurement: CT-scan.;O2sat at the time of hospitalization and discharge. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: Pulse Oximeter.;Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff). Timepoint: Hospitalization time and discharge time. Method of measurement: Blood test.

Secondary Outcome Measures

Name	Time	Method
eed hospitalization in icu. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire.;Mortality. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire.