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This study is for patients suffering from COVID-19 pneumonia (mild to moderate cases) ; especially in developing countries where expensive drugs are not available.
Colchicine is an economically favourable anti inflammatory drug readily Used for gout patients but is being given experimentally in Covid 19 patients .
Study has been designed in this way that drug has been given carefully to patients on which there will be no to minimum side effects . It is only to see beneficial effects if any present in Covid pneumonia patients which will be observed by clinical & lab improvement.
Colchicine, an anti-inflammatory drug used conventionally to treat gout and pericarditis. This study shows effectiveness of colchicine in enhancing clinical outcomes in mildly to moderately severe COVID-19 pneumonia patients.
Improvement will be observed in terms of shorter hospital admissions and oxygen dependency .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine group | Active Comparator | Experimental group will be given tab colchicine 0.5 mg 1 daily in addition to usual treatment for Covid-19 pneumonia mild , moderate cases. |
|
| Controlled group | No Intervention | This group will only be given usual treatment for covid 19 pneumonia ( anti coagulation, steroid, nebulisation) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG Oral Tablet | Drug | Colchicine is anti inflammatory drug which will be given to Covid pneumonia patients and their benefit will be observed in them |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay and oxygen dependence | Patients will be monitored for prolonged hospital stay and decrease /increase of oxygen requirement. | Over a period of 07 days per patient after start of experimental drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce levels of inflammatory markers | There is a surge in inflammatory marker of Covid patients Their pattern will be monitored since the start of experimental medication and after 7 th day of medication. | 7 days per patient |
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity or allergy to colchicine or any of its excipients. Patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m^2 or advanced liver disease (Child-Pugh Class B or C). Patients taking medications known to have significant interactions with colchicine, such as strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole), P-glycoprotein inhibitors (e.g., cyclosporine), or medications associated with myelosuppression (e.g., azathioprine, cyclophosphamide). Patients with pre-existing medical conditions that, in the opinion of the investigator, could pose a significant risk or interfere with the interpretation of the study results (e.g., severe heart failure, uncontrolled arrhythmias, uncontrolled diabetes, or active malignancies).
Pregnant or lactating individuals. Patients deemed by the investigator to be in imminent danger of death or unlikely to survive the duration of study due to some other disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General hospital | Lahore | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |