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

NCT06847204 | Completed Phase 1 DMC

• 1 other identifier: farahkchem@yahoo.com
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID - 19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Reduce levels of inflammatory markers

  7 days per patient

Study Arms (2)

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.

Drug: Colchicine 0.5 MG Oral Tablet

Controlled group

NO INTERVENTION

This group will only be given usual treatment for covid 19 pneumonia ( anti coagulation, steroid, nebulisation)

Interventions

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

Colchicine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zaeema Kanwal: lead

Study Sites (1)

General hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine; Tablets

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zkanwal

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: February 24, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 24, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-02

Locations

PA (1)