Effectiveness of Colchicine Among Patients With COVID-19 Infection

Study Overview
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Brief Summary
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In November 2019, there were a lot of cases of an acute respiratory illness (then named at February 11th as COVID_19) which first case was reported in Wuhan, China,The SARS COV-2 had been spread in a fast way to involve whole world, As it's obvious that Colchicine is a drug that is most commonly and widely used to treat and prevent acute attacks of Gout, other crystal induced arthropathy,colchicine has important role in inhibiting activation of NLRP3 inflammasome these lead to decrease cytokine production , aim of study To evaluate whether colchicine is effective in the treatment of COVID-19 cases. And to measure the effectiveness of colchicine in alleviating and controlling pulmonary and extra pulmonary complications of COVID-19

Detailed Description
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this is an open label, randomize control clinical trial ,the participant will be randomly assign in to two groups ( Group A and Group B), colchicine (group A) will treat with colchicine tablet alone or add to their Current treatment,Colchicine 0.5 mg twice daily (reduce to 0.5 mg/day, in patients with low body weight or develop side effects like gastrointestinal symptoms ),For 14 days or until symptoms subsides, while the control group will treat according to usual treatment guideline in COVID-19.

Official Title
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Effectiveness of Colchicine Among Patients With COVID-19 Infection

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Drug: Colchicine 0.5 MG
* Drug: usual care treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.patients diagnosed clinically or by RT-PCR in nasopharyngeal swab specimens and/ or lung involvement confirm by computed tomography scan compatible with COVID-19patients 2.Age between 18 year and 70 years, 3.body weight > 50 kg, 4.with written informed consent from patients or relatives. - Exclusion Criteria 1 sensitivity to any medications of regimens, 2.e GFR less than 30. 3.pregnancy. 4.malignancy . 5.Participating in another clinical study and refusing to participate in the study at a later date or later, and they are already taking colchicine for other diseases . -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 100 Patients will participate for eligibility and enroll in the study, an open labell randomize control clinical trial will held among patients who will infect with COVID-19 in whom they met the inclusion criteria, either treat at home with healthcare advises and follow up or at centres of COVID-19 in ERBIL city ( Rozhawa emergency hospital, Erbil international private hospital) .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: colchicine drug<br>participant in this group will be given a colchicine tablet alone or add to their Current treatment, Colchicine 0.5 mg twice daily (reduced to 0.5 mg/day, in patients with low body weight or develop side effect like gastrointestinal symptoms ),For 14 days or until symptoms subsides. | Drug: Colchicine 0.5 MG<br>* participant will be given a Colchicine regimen in a dose of 0.5mg twice daily for 14 days or until symptoms subsides,those with low body weight and develop side effect like diarrhea and vomiting dose will be reduced and supportive treatment will be given .<br>* Other names: colchicum;|
| Active Comparator: usual care<br>control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine. | Drug: usual care treatment<br>* control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.<br>* Other names: treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for supplemental oxygen | number of patients need supplemental oxygen | 14 days following randomization | 
| length of hospital stay | number of patients who admit to hospital and duration of stay | 14 days following randomization | 
| need for invasive mechanical ventilation | number of patients need invasive mechanical ventilation | 14 days following randomization | 
| death rate | number of patients who die during randomization | 14 days following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen saturation measurement | Sp02 measurement by pulse oximetry | 14 days following randomization | 
| musculoskeletal symptoms | participants who have back pain and myalgia measure by patient analogue scale of pain | 14 days following randomization | 
| change in severity marker | CRP measurement | 14 days following randomization | 
| change in inflammatory marker | ferritin | 14 days following randomization | 
| change in severity marker | D.Dimer | 14 days following randomization | 
| change in marker | leukocyte | 14 days following randomization | 
| adverse effect | number of participants who develop adverse effect with treatment | 14 days following randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, colchicine, Erbil,Iraq