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Completed

NCT Number: NCT06847204

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

General hospital

Lahore, Punjab Province, Pakistan

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Hospital stay and oxygen dependence

    Time frame: Over a period of 07 days per patient after start of experimental drug

    Patients will be monitored for prolonged hospital stay and decrease /increase of oxygen requirement.

Secondary outcomes

  1. Reduce levels of inflammatory markers

    Time frame: 7 days per patient

    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.

Sponsors and collaborators

Lead sponsor

Zaeema Kanwal

Other Gov

Registry information

Acronym: Colchicine

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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