SARS-CoV-2 Infection (COVID-19)Phase 3COLCHI-COVIDNCT04416334
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS
A Phase 3 study testing Colchicine plus symptomatic treatment (paracetamol) and Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) in people with SARS-CoV-2 Infection (COVID-19), run by Instituto de Investigación Marqués de Valdecilla at 4 sites in Spain.
Trial summary
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- SARS-CoV-2 Infection (COVID-19)
- What is being tested?
- Colchicine plus symptomatic treatment (paracetamol) and Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesSpain
- Study dates
- 19 Aug 2020to 11 Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes who are at least 60 years old.
- Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
- Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
- The patient must possess at least two of the following high-risk criteria
- 60 years of age or older AND
- Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia
- The patient must be able and willing to comply with the requirements of this study protocol.
Who cannot join
- Hospitalized patient or under immediate consideration of doing so
- Patient taking colchicine for other indications
- Patient with history of allergic reaction or sensitivity to colchicine
- Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
- Patient with pre-existing progressive neuromuscular disease
- Patient with kidney damage and estimated glomerular filtrate rate <30 ml/m at 1732
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- Patient undergoing chemotherapy for cancer, including haematological malignancies.
- Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
- Immunosuppressive treatment
- History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
- If the investigator considers it, for any reason, to be an inadequate candidate.
- Patient and/or legal representative will not have signed the informed consent form.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Atención primaria (Área 2)
Laredo, Cantabria
Gerencia de atención primaria (Área 3)
Reinosa, Cantabria
Atencion primaria (AREA 1)
Santander, Cantabria
Gerencia de atención primaria (área 4)
Torrelavega, Cantabria
About this study
Official title: PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
Read the detailed description
The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.
The secondary objective is to determine the safety of colchicines in this patient population.
Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
- Conditions
- SARS-CoV-2 Infection (COVID-19)
- Being tested
- Colchicine plus symptomatic treatment (paracetamol), Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
- Keywords
- 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.
Colchicine plus symptomatic treatment (paracetamol)Drug
Colchicine plus symptomatic treatment (paracetamol).
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)Drug
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
| Study group | Role | What they receive |
|---|---|---|
| Colchicine plus symptomatic treatment (paracetamol). | Experimental | Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.
All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice. Receives: Drug: Colchicine plus symptomatic treatment (paracetamol) |
| Symptomatic treatment | Active comparator | Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations). Receives: Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who die due to COVID-19 infection
Measured: 21 days post-randomization
Number of participants who require hospitalization due to COVID-19 infection
Measured: 21 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Aug 2020
- Primary completion1 Jun 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Infection (COVID-19)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Gerencia de atención primaria área 1, Gerencia de atención primaria área 2, Gerencia Atencion Primaria Area 3, Gerencia de atención primaria área 4
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416334
- Sponsor's protocol ID
- COLCHICOVID
- Acronym
- COLCHI-COVID
- Status last verified
- Nov 2023
- First submitted
- 3 Jun 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Estebanez EB, Alconero LL, Fernandez BJ, Marguello MG, Caro JCL, Vallejo JD, Sampedro MF, Cacho PM, Espiga CR, Saiz MMG. The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study. Trials. 2021 Sep 6;22(1):590. doi: 10.1186/s13063-021-05544-7.
PubMed 34488841
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04416334
- Acronym / sponsor ID
- COLCHI-COVID / COLCHICOVID
- Conditions
- SARS-CoV-2 Infection (COVID-19)
- Keywords
- colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Collaborators
- Gerencia de atención primaria área 1, Gerencia de atención primaria área 2, Gerencia Atencion Primaria Area 3, Gerencia de atención primaria área 4
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 4 Jun 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 a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
Detailed description
The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.
The secondary objective is to determine the safety of colchicines in this patient population.
Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine plus symptomatic treatment (paracetamol). | Experimental | Drug: Colchicine plus symptomatic treatment (paracetamol)Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced. All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice. |
| Symptomatic treatment | Active comparator | Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes who are at least 60 years old.
- Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
- Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
- The patient must possess at least two of the following high-risk criteria
- The patient must be able and willing to comply with the requirements of this study protocol.
Key exclusion criteria (12 listed)
- Hospitalized patient or under immediate consideration of doing so
- Patient taking colchicine for other indications
- Patient with history of allergic reaction or sensitivity to colchicine
- Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
- Patient with pre-existing progressive neuromuscular 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 plus symptomatic treatment (paracetamol)Colchicine plus symptomatic treatment (paracetamol). | Drug | Colchicine plus symptomatic treatment (paracetamol). |
| Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations). | Drug | Symptomatic treatment |
Primary outcome
Number of participants who die due to COVID-19 infection
Time frame: 21 days post-randomization
Number of participants who require hospitalization due to COVID-19 infection
Time frame: 21 days post-randomization
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 8 Nov 2023.
- Derived from this study: PubMed 34488841Estebanez EB, Alconero LL, Fernandez BJ, Marguello MG, Caro JCL, Vallejo JD, Sampedro MF, Cacho PM, Espiga CR, Saiz MMG. The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study. Trials. 2021 Sep 6;22(1):590. doi: 10.1186/s13063-021-05544-7.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine plus symptomatic treatment (paracetamol) and Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) in people with SARS-CoV-2 Infection (COVID-19), run by Instituto de Investigación Marqués de Valdecilla at 4 sites 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 12 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
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?
Number of participants who die due to COVID-19 infection (time frame: 21 days post-randomization). 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?
On the ClinicalTrials.gov record for NCT04416334, which also lists 1 linked publication.
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 8 Nov 2023.