Effectiveness of Colchicine Among Patients With COVID-19 Infection
- Conditions
- Coronavirus Infection
- Interventions
- Drug: usual care treatment
- Registration Number
- NCT04867226
- Lead Sponsor
- Hawler Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 .
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description usual care usual care treatment control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine. colchicine drug Colchicine 0.5 MG 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.
- Primary Outcome Measures
Name Time Method need for invasive mechanical ventilation 14 days following randomization number of patients need invasive mechanical ventilation
length of hospital stay 14 days following randomization number of patients who admit to hospital and duration of stay
need for supplemental oxygen 14 days following randomization number of patients need supplemental oxygen
death rate 14 days following randomization number of patients who die during randomization
- Secondary Outcome Measures
Name Time Method change in inflammatory marker 14 days following randomization ferritin
change in severity marker 14 days following randomization D.Dimer
change in marker 14 days following randomization leukocyte
musculoskeletal symptoms 14 days following randomization participants who have back pain and myalgia measure by patient analogue scale of pain
adverse effect 14 days following randomization number of participants who develop adverse effect with treatment
oxygen saturation measurement 14 days following randomization Sp02 measurement by pulse oximetry
Trial Locations
- Locations (1)
Hawler medical university ,Rozhawa emergency hospital
🇮🇶Erbil, Iraq