Coronavirus Infection
Conditions
Keywords
covid-19, colchicine, Erbil,Iraq
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.
Interventions
DRUGColchicine 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 .
control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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) .
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 . \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| need for supplemental oxygen | 14 days following randomization | number of patients need supplemental oxygen |
| length of hospital stay | 14 days following randomization | number of patients who admit to hospital and duration of stay |
| need for invasive mechanical ventilation | 14 days following randomization | number of patients need invasive mechanical ventilation |
| death rate | 14 days following randomization | number of patients who die during randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in marker | 14 days following randomization | leukocyte |
| oxygen saturation measurement | 14 days following randomization | Sp02 measurement by pulse oximetry |
| adverse effect | 14 days following randomization | number of participants who develop adverse effect with treatment |
| musculoskeletal symptoms | 14 days following randomization | participants who have back pain and myalgia measure by patient analogue scale of pain |
| change in severity marker | 14 days following randomization | CRP measurement |
| change in inflammatory marker | 14 days following randomization | ferritin |
Countries
Iraq
Outcome results
None listed