COVID-19
Conditions
Brief summary
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Detailed description
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.
Interventions
1.5 mg loading then 0.5 mg BID P.O
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.
Exclusion criteria
* Patient who is not willing to enter in study * Known hypersensitivity to colchicine * Hepatic failure * Renal failure with eGFR\<20 ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRPxN/R ratio change | 2 weeks | increasing inflammatory status |
| Clinical deterioration by the WHO definition | 2 weeks | including change in fever or O2 Saturation |
| PCR Viral Load | 2 weeks | change in RT-PCR |
| CT severity involvement index | 2weeks | change in CT involvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDH change | 2 weeks | change in LDH |
Countries
Iran
Outcome results
None listed