COVID-19Phase 2COLVID-19NCT04375202
Colchicine in COVID-19: a Pilot Study
A Phase 2 study testing Colchicine 1 MG Oral Tablet in people with COVID-19, run by University Of Perugia at 2 sites in Italy.
Trial summary
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Colchicine 1 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Apr 2020to 31 Oct 2021
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical/instrumental diagnosis of pneumonia
- Oxygen saturation at rest in ambient air ≤94%
- PaO2/FiO2 ratio of 350 to 200
Who cannot join
- Known hypersensitivity to colchicine or its excipients
- Severe diarrhea
- Patients who cannot take oral therapy
- Pregnant and lactating patients
- Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)
- Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
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- Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
- Neutrophils <1.000 / mmc
- Platelets <50.000 / mmc
- Bowel diverticulitis or perforation
- Patients already in ICU or requiring mechanical ventilation
- Patients receiving Tocilizumab
- Patients already enrolled in other clinical trials
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Associazione Italiana Pneumologi Ospedalieri
Milan
Società Italiana di Reumatologia
Milan
About this study
Official title: Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
Read the detailed description
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.
One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.
- Conditions
- COVID-19
- Being tested
- Colchicine 1 MG Oral Tablet
- Keywords
- COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 1 MG Oral TabletDrug
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine plus current care | Experimental | Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator. Receives: Drug: Colchicine 1 MG Oral Tablet |
| Current care alone | No intervention | Current care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of entering the critical stage
Comply with any of the followings:
- Respiratory failure occurs and requires mechanical ventilation;
- Patients combined with other organ failure need ICU monitoring and treatment
- Death
Measured: [1 month]
Secondary outcomes (4)
Trend of White blood cell count
Measured: [up to 30 days]
Change of the "Sequential Organ failure Assessment" (SOFA)
Measured: [up to 30 days]
Rate of biochemical criterion (CK, ALT, ferritin) recovery
Measured: [up to 30 days]
Rate of disease remission
Comply with any of the followings:
- No fever, cough and other symptoms;
- SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation
Measured: [up to 30 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start18 Apr 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: Insufficient rate of patient accrual and newly available scientific evidence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Roberto Gerli, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375202
- Sponsor's protocol ID
- 2020-001475-33
- Acronym
- COLVID-19
- Status last verified
- Nov 2022
- First submitted
- 29 Apr 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17.
PubMed 32317220Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
PubMed 34658014
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
- ClinicalTrials.gov ID
- NCT04375202
- Acronym / sponsor ID
- COLVID-19 / 2020-001475-33
- Conditions
- COVID-19
- Keywords
- COVID, COVID-19, CORONAVIRUS, SARS-COV-2, COLCHICINE, IL-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient rate of patient accrual and newly available scientific evidence
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 5 May 2020 (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 is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
Detailed description
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.
One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine plus current care | Experimental | Drug: Colchicine 1 MG Oral TabletColchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator. |
| Current care alone | No intervention | –Current care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical/instrumental diagnosis of pneumonia
- Oxygen saturation at rest in ambient air ≤94%
- PaO2/FiO2 ratio of 350 to 200
Key exclusion criteria (13 listed)
- Known hypersensitivity to colchicine or its excipients
- Severe diarrhea
- Patients who cannot take oral therapy
- Pregnant and lactating patients
- Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)
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 1 MG Oral TabletTablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days. | Drug | Colchicine plus current care |
Primary outcome
Rate of entering the critical stage
Time frame: [1 month]
Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Patients combined with other organ failure need ICU monitoring and treatment 3. Death
4 secondary outcomes
Trend of White blood cell count
Time frame: [up to 30 days]
Change of the "Sequential Organ failure Assessment" (SOFA)
Time frame: [up to 30 days]
Rate of biochemical criterion (CK, ALT, ferritin) recovery
Time frame: [up to 30 days]
Rate of disease remission
Time frame: [up to 30 days]
Results and safety
The study was stopped early (reason given: Insufficient rate of patient accrual and newly available scientific evidence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 32317220Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17.
- Derived from this study: PubMed 34658014Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 1 MG Oral Tablet in people with COVID-19, run by University Of Perugia at 2 sites in Italy.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 phase mean?
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 was stopped early (reason given: Insufficient rate of patient accrual and newly available scientific evidence). Results are not available in the source record.
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?
Rate of entering the critical stage (time frame: [1 month]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375202, which also lists 2 linked publications.
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 7 Nov 2022.