EFFICACY OF COLCHICINE IN IMPROVING CLINICAL OUTCOMES IN PATIENTS WITH MILD TO MODERATE COVID-19 PNEUMONIA IN LAHORE: A RANDOMIZED CONTROL TRIAL

Launched by ZAEEMA KANWAL · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called colchicine in helping patients with mild to moderate COVID-19 pneumonia. Colchicine is an affordable anti-inflammatory drug that is commonly used to treat gout, and researchers want to see if it can also provide benefits for people suffering from COVID-19 pneumonia, particularly in places where expensive treatments may not be available.

To participate in the trial, patients need to have a confirmed COVID-19 infection and show certain signs of pneumonia, such as high levels of inflammation in their blood and difficulty breathing. They must also be able to give their consent to join the study and meet specific health criteria to ensure their safety. Participants will receive colchicine and will be monitored closely for any improvements in their condition, as well as any potential side effects. The study is not currently recruiting participants, but it aims to find out if colchicine can help improve health outcomes for those affected by COVID-19 pneumonia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with laboratory-confirmed COVID-19 infection through a PCR test using a nasopharyngeal swab specimen, or the presence of at least two of the following four inflammatory criteria: C-reactive protein (CRP) level \> 4 mg/dL, D-dimer level \> 1 mg/L, ferritin level \> 1000 ng/mL, along with fever ≥ 38 °C and respiratory distress Patients having supplemental oxygen requirement. Patients who provide informed consent to participate in the study. Patients having normal levels of serum Ca2+ and K+; QT interval \<450 ms at 12 derivations ECG (Colchicine has been associated with potential cardiac side effects, including disturbances in electrolyte levels and QT interval prolongation. Normal levels of these electrolytes help minimise the risk of cardiac arrhythmias or other adverse events.
• 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