COVID - 19Phase 1/2ColchicineNCT06847204
EFFICACY OF COLCHICINE IN IMPROVING CLINICAL OUTCOMES IN PATIENTS WITH MILD TO MODERATE COVID-19 PNEUMONIA IN LAHORE: A RANDOMIZED CONTROL TRIAL
A Phase 1/2 study testing Colchicine 0.5 MG Oral Tablet in people with COVID - 19, run by Zaeema Kanwal at 1 site in Pakistan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID - 19
- What is being tested?
- Colchicine 0.5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Feb 2025to 24 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 .
- Conditions
- COVID - 19
- Being tested
- Colchicine 0.5 MG Oral Tablet
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral TabletDrug
Colchicine is anti inflammatory drug which will be given to Covid pneumonia patients and their benefit will be observed in them
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay and oxygen dependence
Patients will be monitored for prolonged hospital stay and decrease /increase of oxygen requirement.
Measured: Over a period of 07 days per patient after start of experimental drug
Secondary outcomes (1)
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.
Measured: 7 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start24 Feb 2025
- Primary completion30 May 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zaeema Kanwal
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zaeema Kanwal, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847204
- Sponsor's protocol ID
- farahkchem@yahoo.com
- Acronym
- Colchicine
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF COLCHICINE IN IMPROVING CLINICAL OUTCOMES IN PATIENTS WITH MILD TO MODERATE COVID-19 PNEUMONIA IN LAHORE: A RANDOMIZED CONTROL TRIAL
- ClinicalTrials.gov ID
- NCT06847204
- Acronym / sponsor ID
- Colchicine / farahkchem@yahoo.com
- Conditions
- COVID - 19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zaeema KanwalOther government
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Active comparator | Drug: Colchicine 0.5 MG Oral TabletExperimental 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG Oral TabletColchicine is anti inflammatory drug which will be given to Covid pneumonia patients and their benefit will be observed in them | Drug | Colchicine group |
Primary outcome
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.
1 secondary outcome
Reduce levels of inflammatory markers
Time frame: 7 days per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Colchicine 0.5 MG Oral Tablet in people with COVID - 19, run by Zaeema Kanwal at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital stay and oxygen dependence (time frame: Over a period of 07 days per patient after start of experimental drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.