NCT04867226

Effectiveness of Colchicine Among Patients With COVID-19 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG	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 .
DRUG	usual care treatment	control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.

Timeline

• Start date: 2021-05-08
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-04-30
• Last updated: 2021-06-22

Locations

1 site across 1 country: Iraq