Corona Virus InfectionPhase 3(COLCOVID19)NCT04539873
Impact of Colchicine in Hospitalized Colombian Patients With COVID-19
A Phase 3 study testing Colchicine 0.5 MG in people with Corona Virus Infection, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
Trial summary
This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteColombia
- Study dates
- 30 Apr 2021to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old.
- Laboratory-confirmed SARS-CoV-2 infection: infection confirmed with nasopharyngeal swab by positive RT PCR in the last 48 hours.
- Hospital admission for COVID-19 in the previous 48 hours.
- Clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen requirement for nasal contact lenses or mask) of the WHO classification (see ANNEX 2).
- The patient must be able and willing to provide informed written consent before performing study procedures.
- Patient confirmed to covid19 as positive by positive PCR test
Who cannot join
- Pregnancy, nursing mothers, and women of childbearing potential who are unable to use adequate contraception.
- Known hypersensitivity or other clear contraindication to the use of colchicine.
- History of end-stage renal disease (eGFR <30 ml / min / 1.73 m2).
- Medical history of cirrhosis (Child-Pugh C), liver failure, chronic active hepatitis, or severe liver disease defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 times the upper limit of normal.
- History of pre-existing neuromuscular disease.
- Previous severe hematologic disease or bleeding disorders.
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- Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea, or malabsorptive syndrome.
- Colchicine treatment for other indications.
- Treatment with immunosuppressive/immunomodulatory agents, including glucocorticoids, antivirals, antimalarials, and IL 6 antagonists for 30 days prior to enrollment.
- Use of other investigational drugs at the time of inclusion, or during the 30 days prior to inclusion.
- Any medical condition or disease that, in the opinion of the investigator, may place the patient at unacceptable risk to participate in the study.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Universitaria de Ciencias de La Salud
Bogota, Cundinamarca, 111411
About this study
This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
Read the detailed description
Introduction: COVID-19 and mortality associated with acute respiratory distress syndrome (ARDS) pose a global public health problem. The increase in spread and associated mortality poses a scenario where cost-effective therapeutic options are urgently and effectively proposed to control and reduce the pandemic and even to reduce the number of deaths Objective: To evaluate the efficacy and safety of oral colchicine plus treatment standard versus standard treatment in the clinical course of SARS-CoV-2 virus infection, in a population group with moderate COVID-19 involvement and requiring hospitalization. Methodology: A prospective, open, randomized, parallel-group study, the sample size of 120 subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with 0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day 28, evaluating physical examination, clinical situation, laboratories, and adverse events. The primary efficacy data correspond to the deterioration in the clinical status of the patients through the semiquantitative ordinal scale suggested by the WHO R\&D committee. Expected results: It is expected to find out how, through different pathways, colchicine could act in modulating or preventing the appearance of ARDS associated with COVID-19, its possible effects on viral replication and antigenic presentation.
- Conditions
- Corona Virus Infection
- Being tested
- Colchicine 0.5 MG, CONTROL GROUP
- Keywords
- Colchicine, Gout, Antirheumatic Agents, Tubulin Modulators
- Medical subject headings
- Coronavirus Infections, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Also called EXPOSED GROUP
Patientes in this arm will receive study medication colchicine 1,5 orally on the first day (initially two pills of 0,5 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator.
CONTROL GROUPCombination product
Also called standard treatment
In this case, the centers where the patients are enrolled will adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases)
| Study group | Role | What they receive |
|---|---|---|
| COLHICINE PLUS STANDARD TREATMENT | Active comparator | Patients treated in the exposed group will consist of a decreasing dose of colchicine: a dose of 1.5 mg orally on the first day (initial 1 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator. Receives: Drug: Colchicine 0.5 MG |
| STANDARD TREATMENT | Placebo comparator | In this case, the centers where the patients will be included adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases), and to standard treatment Receives: Combination Product: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who die or require transfer to Intesive care unit
The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection
Measured: In the first 15 days after ramdomization
Secondary outcomes (1)
Number of participants who die
The secondary end point is the ocurrence of death in the 15 days after ramdomization
Measured: 15 days after ramdomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start30 Apr 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Why it stopped: non-inclusion of patients in the study effectively
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Corona Virus 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
- Model description
- This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization. Patients diagnosed with COVID-19 and meeting all eligibility criteria will be randomized for treatment in a 1: 1 ratio through a central voice response system. Randomization will be balanced in each of the 2 strata: 1) hospitalized patients with clinical stage 4 (requirement of supplemental oxygen by nasal contact lenses or mask) of the World Health Organization (WHO) classification, see ANNEX 2, who will receive in addition to the usual treatment for COVID-19 oral colchicine (exposed group); 2) hospitalized patients with clinical stage 4 of the WHO classification who will receive the usual treatment for COVID-19 (control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de San Jose
- Responsible party
- Sponsor
- Investigators
- JHON JAIME SPROCKEL, MD; IM, Study chair, Hospital de San Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539873
- Sponsor's protocol ID
- 5175
- Acronym
- (COLCOVID19)
- Status last verified
- Feb 2022
- First submitted
- 29 Aug 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
PubMed 32020029Savarino A, Di Trani L, Donatelli I, Cauda R, Cassone A. New insights into the antiviral effects of chloroquine. Lancet Infect Dis. 2006 Feb;6(2):67-9. doi: 10.1016/S1473-3099(06)70361-9. No abstract available.
PubMed 16439323Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28.
PubMed 32346093
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Colchicine in Hospitalized Colombian Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04539873
- Acronym / sponsor ID
- (COLCOVID19) / 5175
- Conditions
- Corona Virus Infection
- Keywords
- Colchicine, Gout, Antirheumatic Agents, Tubulin Modulators
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: non-inclusion of patients in the study effectively
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Hospital de San Jose
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 7 Sep 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 IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
Detailed description
Introduction: COVID-19 and mortality associated with acute respiratory distress syndrome (ARDS) pose a global public health problem. The increase in spread and associated mortality poses a scenario where cost-effective therapeutic options are urgently and effectively proposed to control and reduce the pandemic and even to reduce the number of deaths Objective: To evaluate the efficacy and safety of oral colchicine plus treatment standard versus standard treatment in the clinical course of SARS-CoV-2 virus infection, in a population group with moderate COVID-19 involvement and requiring hospitalization. Methodology: A prospective, open, randomized, parallel-group study, the sample size of 120 subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with 0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day 28, evaluating physical examination, clinical situation, laboratories, and adverse events. The primary efficacy data correspond to the deterioration in the clinical status of the patients through the semiquantitative ordinal scale suggested by the WHO R\&D committee. Expected results: It is expected to find out how, through different pathways, colchicine could act in modulating or preventing the appearance of ARDS associated with COVID-19, its possible effects on viral replication and antigenic presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization. Patients diagnosed with COVID-19 and meeting all eligibility criteria will be randomized for treatment in a 1: 1 ratio through a central voice response system. Randomization will be balanced in each of the 2 strata: 1) hospitalized patients with clinical stage 4 (requirement of supplemental oxygen by nasal contact lenses or mask) of the World Health Organization (WHO) classification, see ANNEX 2, who will receive in addition to the usual treatment for COVID-19 oral colchicine (exposed group); 2) hospitalized patients with clinical stage 4 of the WHO classification who will receive the usual treatment for COVID-19 (control group).
| Arm | Type | Receives |
|---|---|---|
| COLHICINE PLUS STANDARD TREATMENT | Active comparator | Drug: Colchicine 0.5 MGPatients treated in the exposed group will consist of a decreasing dose of colchicine: a dose of 1.5 mg orally on the first day (initial 1 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator. |
| STANDARD TREATMENT | Placebo comparator | Combination Product: CONTROL GROUPIn this case, the centers where the patients will be included adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases), and to standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18 years old.
- Laboratory-confirmed SARS-CoV-2 infection: infection confirmed with nasopharyngeal swab by positive RT PCR in the last 48 hours.
- Hospital admission for COVID-19 in the previous 48 hours.
- Clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen requirement for nasal contact lenses or mask) of the WHO classification (see ANNEX 2).
- The patient must be able and willing to provide informed written consent before performing study procedures.
Key exclusion criteria (11 listed)
- Pregnancy, nursing mothers, and women of childbearing potential who are unable to use adequate contraception.
- Known hypersensitivity or other clear contraindication to the use of colchicine.
- History of end-stage renal disease (eGFR <30 ml / min / 1.73 m2).
- Medical history of cirrhosis (Child-Pugh C), liver failure, chronic active hepatitis, or severe liver disease defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 times the upper limit of normal.
- History of pre-existing 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 0.5 MGAlso: EXPOSED GROUPPatientes in this arm will receive study medication colchicine 1,5 orally on the first day (initially two pills of 0,5 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator. | Drug | COLHICINE PLUS STANDARD TREATMENT |
| CONTROL GROUPAlso: standard treatmentIn this case, the centers where the patients are enrolled will adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases) | Combination product | STANDARD TREATMENT |
Primary outcome
Number of participants who die or require transfer to Intesive care unit
Time frame: In the first 15 days after ramdomization
The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection
1 secondary outcome
Number of participants who die
Time frame: 15 days after ramdomization
Results and safety
The study was stopped early (reason given: non-inclusion of patients in the study effectively). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Results publication: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Results publication: PubMed 32020029Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
- Results publication: PubMed 16439323Savarino A, Di Trani L, Donatelli I, Cauda R, Cassone A. New insights into the antiviral effects of chloroquine. Lancet Infect Dis. 2006 Feb;6(2):67-9. doi: 10.1016/S1473-3099(06)70361-9. No abstract available.
- Results publication: PubMed 32346093Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28.
- 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.
JHON JAIME SPROCKEL, MD; IM study chair
Hospital de San Jose
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 Colchicine 0.5 MG in people with Corona Virus Infection, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
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 6 inclusion and 11 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 23 Feb 2022. 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 Colombia. 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?
The study was stopped early (reason given: non-inclusion of patients in the study effectively). 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?
Number of participants who die or require transfer to Intesive care unit (time frame: In the first 15 days after ramdomization). 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 NCT04539873, which also lists 4 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 23 Feb 2022.