COVID-19 InfectionPhase 3NCT04997551
Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19
A Phase 3 study testing Colchcine in people with COVID-19 Infection, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial summary
EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups: Experimental group: colchicine for 2 weeks orally at the doses… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Colchcine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 752 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2020to 1 Jan 2022
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 - Acute symptoms compatible with SARS-CoV-2 infection: fever, cough, myalgia, dysgeusia / ageusia, dyspnea, pulmonary infiltrates on X-ray / CT, or any sign / symptom attributable to said infection
- 2. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).
- 3.> 18 years.
- 4. <2 weeks from the onset of symptoms.
- 5. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)
- 6. Some analytical degree of moderate inflammation defined by PCR between 20 and 80 mg / L and / or ferritin between the high limit of normality (LAN) and 3 times said LAN
- 7. Signing of the Informed Consent, or acceptance of oral consent before witnesses.
Who cannot join
- 1. Drug allergy.
- 2. Intolerance to lactose and / or cow's milk proteins.
- 3. Renal failure with GFR <30 ml / min.
- 4. Liver cirrhosis or severe liver failure
- 5. Pregnancy or breastfeeding.
- 6. Blood dyscrasias or cardiac disorders that in the opinion of the investigator contraindicate the use of colchicine.
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- 7. Pre-existing degenerative neuromuscular disease.
- 8. Acute or chronic diarrhea or malabsorptive syndrome that in the judgment of the clinician contraindicates the use of colchicine.
- 9. CRP> 80 mg / L or ferritin> 3 times LAN
- 10. Shock or hemodynamic instability.
- 11. Respiratory distress measured by PaO2 / FIO2 <300 or baseline O2 saturation ≤ 93%.
- 12. Patients undergoing mechanical ventilation.
- 13. Chronic treatment with any drug that, in the opinion of the investigator, interacts with colchicine and cannot be discontinued during the clinical trial, unacceptably increasing the risk of toxicity (digoxin, cyclosporine, etc.)
- 14. Have received any dose of colchicine, tocilizumab, any antiL6 or antiL1 drug.
- 15. Current treatment with corticosteroids (except chronic corticosteroid therapy without recent increase in dose).
- 16. Participation in any other clinical trial of patients with COVID-19.
- 17. Any other condition that, in the opinion of the investigator, contraindicates the use of colchicine or puts the subject at risk due to their participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Biodonostia Health Research Institute
San Sebastián, Guipuzcoa, 20014
About this study
Official title: Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized Patients With Covid-19 Infection
EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:
- Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.
- Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.
- Conditions
- COVID-19 Infection
- Being tested
- Colchcine
- Keywords
- covid-19, colchicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchcineDrug
In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs:
- Day 1: 1 single dose of 1 mg orally, in a single dose.
- Days 2 to 6: 0.5 mg every 12 hours v.o.
- Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts. or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day.
In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be:
- Days 1 to 14: 0.5 mg / day
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | EC Experimental group: colchicine for 2 weeks orally added to standard treatment. Receives: Drug: Colchcine |
| Placebo | Placebo comparator | Control group: placebo for 2 weeks added to standard treatment. Receives: Drug: Colchcine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.
Although the definition of respiratory distress usually includes a radiological criterion, as long as the oxygenation deficit is not attributable to another cause by the clinician, we do not consider it essential to perform a chest X-ray to confirm the diagnosis of distress because it does not correspond to clinical practice routine and the X-ray result does not change the patient's management.
Measured: 30 days (from day +1 to day +30)
Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.
Measured: 30 days (from day +1 to day +30)
Secondary outcomes (6)
Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:
- Not hospitalized, usual activities not limited
- Not hospitalized with limitation for usual activities
- Hospitalized, without oxygen requirements
- Hospitalized with oxygen requirements
- Hospitalized with oxygen in a reservoir, non-invasive mechanical ventilation or high-flow oxygen device
- Hospitalized with the need for invasive mechanical ventilation
- Deceased
Measured: 30 days (from day +1 to day +30)
Time (days) until death
Measured: 30 days (from day +1 to day +30)
Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.
Measured: 30 days (from day +1 to day +30)
Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.
Measured: 30 days (from day +1 to day +30)
Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.
Measured: 30 days (from day +1 to day +30)
Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.
Measured: 30 days (from day +1 to day +30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start8 Sep 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997551
- Sponsor's protocol ID
- EC CORONACOLCHI
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized Patients With Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04997551
- Acronym / sponsor ID
- EC CORONACOLCHI
- Conditions
- COVID-19 Infection
- Keywords
- covid-19, colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 9 Aug 2021 (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.
EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:
- Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.
- Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: ColchcineEC Experimental group: colchicine for 2 weeks orally added to standard treatment. |
| Placebo | Placebo comparator | Drug: ColchcineControl group: placebo for 2 weeks added to standard treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1 - Acute symptoms compatible with SARS-CoV-2 infection: fever, cough, myalgia, dysgeusia / ageusia, dyspnea, pulmonary infiltrates on X-ray / CT, or any sign / symptom attributable to said infection
- 2. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).
- 3.> 18 years.
- 4. <2 weeks from the onset of symptoms.
- 5. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)
Key exclusion criteria (17 listed)
- 1. Drug allergy.
- 2. Intolerance to lactose and / or cow's milk proteins.
- 3. Renal failure with GFR <30 ml / min.
- 4. Liver cirrhosis or severe liver failure
- 5. Pregnancy or breastfeeding.
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 |
|---|---|---|
| ColchcineIn patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs: * Day 1: 1 single dose of 1 mg orally, in a single dose. * Days 2 to 6: 0.5 mg every 12 hours v.o. * Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts. or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day. In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be: o Days 1 to 14: 0.5 mg / day | Drug | Colchicine, Placebo |
Primary outcome
Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.
Time frame: 30 days (from day +1 to day +30)
Although the definition of respiratory distress usually includes a radiological criterion, as long as the oxygenation deficit is not attributable to another cause by the clinician, we do not consider it essential to perform a chest X-ray to confirm the diagnosis of distress because it does not correspond to clinical practice routine and the X-ray result does not change the patient's management.
Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.
Time frame: 30 days (from day +1 to day +30)
6 secondary outcomes
Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:
Time frame: 30 days (from day +1 to day +30)
Time (days) until death
Time frame: 30 days (from day +1 to day +30)
Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.
Time frame: 30 days (from day +1 to day +30)
Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.
Time frame: 30 days (from day +1 to day +30)
Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.
Time frame: 30 days (from day +1 to day +30)
Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.
Time frame: 30 days (from day +1 to day +30)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchcine in people with COVID-19 Infection, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Aug 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30. (time frame: 30 days (from day +1 to day +30)). The study lists 2 primary outcomes in all. 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 9 Aug 2021.