Using colchicine to improve outcomes in mild to moderate COVID-19 pneumonia

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

This study tests if colchicine, a medication usually used for gout, can help people with mild to moderate COVID-19 pneumonia feel better and reduce their need for hospital care.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Lahore General Hospital (Government)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Lahore, Punjab)
• Trial ID: NCT06847204 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of colchicine, an anti-inflammatory medication traditionally used for gout, in patients with mild to moderate COVID-19 pneumonia. The study aims to determine if colchicine can enhance clinical outcomes, such as reducing hospital stays and oxygen dependency, in a population where more expensive treatments may not be accessible. Participants will be closely monitored for clinical and laboratory improvements while minimizing potential side effects associated with the drug.

Who should consider this trial

Good fit: Ideal candidates include patients with laboratory-confirmed COVID-19 pneumonia who meet specific inflammatory criteria and require supplemental oxygen.

Not a fit: Patients with severe COVID-19 pneumonia or those with known hypersensitivity to colchicine will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an affordable option for improving recovery in patients with mild to moderate COVID-19 pneumonia.

How similar studies have performed: While colchicine has been used in other contexts, this specific application for COVID-19 pneumonia is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Lahore, Punjab

• General hospital — Lahore, Punjab, Pakistan (Recruiting)

Study contacts

• Study coordinator: zaeema Kanwal, MBBS

Conditions COVID - 19