Clinical trial NCT04867226: Effectiveness of Colchicine Among Patients With COVID-19 Infection
Official title: Effectiveness of Colchicine Among Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus Infection
Keywords: covid-19, colchicine
Erbil,Iraq
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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) .
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

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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 .

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Primary outcomes:
measure: need for supplemental oxygen
timeFrame: 14 days following randomization
measure: length of hospital stay
timeFrame: 14 days following randomization
measure: need for invasive mechanical ventilation
timeFrame: 14 days following randomization
measure: death rate
timeFrame: 14 days following randomization
Secondary outcomes:
measure: oxygen saturation measurement
timeFrame: 14 days following randomization
measure: musculoskeletal symptoms
timeFrame: 14 days following randomization
measure: change in severity marker
timeFrame: 14 days following randomization
measure: change in inflammatory marker
timeFrame: 14 days following randomization
measure: change in severity marker
timeFrame: 14 days following randomization
measure: change in marker
timeFrame: 14 days following randomization
measure: adverse effect
timeFrame: 14 days following randomization
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler medical university ,Rozhawa emergency hospital
Study officials:
affiliation: assistant professor in medicine,consultant Rheumatologist
name: Dashty Albustany, MBChB.FRCP
role: STUDY_DIRECTOR
affiliation: M.B.CH.B, doctor Rheumatology
name: Aryan MF Jalal
role: PRINCIPAL_INVESTIGATOR
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citation: Crittenden DB, Lehmann RA, Schneck L, Keenan RT, Shah B, Greenberg JD, Cronstein BN, Sedlis SP, Pillinger MH. Colchicine use is associated with decreased prevalence of myocardial infarction in patients with gout. J Rheumatol. 2012 Jul;39(7):1458-64. doi: 10.3899/jrheum.111533. Epub 2012 Jun 1.
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