COVIDPhase 2ColchiVIDNCT04367168
Colchicine in Patients With Mild and Severe Coronavirus Disease
A Phase 2 study testing Colchicine in people with COVID, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteMexico
- Study dates
- 27 May 2020to 16 Aug 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Diagnosed with COVID-19 with mild or severe disease
- Who must receive in-hospital care at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Who are able to take pills PO
Who cannot join
- 1. Concomitant participation in another clinical trial. 2. Hypersensitivity to colchicine 3. Pregnancy and lactation 4. Over 70 years 5. Kidney failure with creatinine clearance <30 mL / min. 6. Known liver failure 7. Concomitant medication that has interactions with colchicine and that due to its indication cannot be suspended or substituted
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, 14080
About this study
Official title: Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection
The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.
Read the detailed description
This a placebo-controlled double-blind clinical trial to test the efficacy and security of colchicine 1.5 mg at day one followed by 0.5 mg BID to complete 10 days of treatment. The researchers will recruit patients 18-70 years of age who are hospitalized because of the diagnosis of mild or severe COVID-19. Patients will be randomized to receive one of the treatment arms, colchicine or placebo. The aim of the study is to evaluate if colchicine may be able to improve the outcomes in patients with mild and severe COVID-19. Patients will be followed-up during the entire hospitalization time and during convalescence. The importance of this intervention is highlighted because currently, there is not an effective treatment for the virus, nor for the prevention of the cytokine storm or the disseminated intravascular coagulation. Therefore, an early intervention to prevent the development of these complications would be valuable to prevent the morbi-morbidity secondary to severe and critical COVID-19
- Conditions
- COVID
- Being tested
- Colchicine, Placebo oral tablet
- Keywords
- Colchicine, Coronavirus, Inflammation, Cytokine storm, Clots
- Medical subject headings
- Coronavirus Infections, Inflammation, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Perrigo
Colchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19
Placebo oral tabletDrug
Also called Armstrong
Placebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Colchicine PO Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Placebo PO Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels
Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin
Measured: Up to 24 days
Progression to severe disease
At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start27 May 2020
- Primary completion27 Apr 2021
- Study completion16 Aug 2021
Why it stopped: The intervention was not effective for the outcomes
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 COVIDStudies 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
- Model description
- Double-blind placebo-controlled clinical trial to test the security and efficacy of colchicine at a dose of 1.5 mg PO at day 1 followed by 0.5 mg PO BID to complete 10 days of treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José J Torres-Ruiz, MD, MSc, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367168
- Sponsor's protocol ID
- 337420-21-1
- Acronym
- ColchiVID
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Absalon-Aguilar A, Rull-Gabayet M, Perez-Fragoso A, Mejia-Dominguez NR, Nunez-Alvarez C, Kershenobich-Stalnikowitz D, Sifuentes-Osornio J, Ponce-de-Leon A, Gonzalez-Lara F, Martin-Nares E, Montesinos-Ramirez S, Ramirez-Alemon M, Ramirez-Rangel P, Marquez MF, Plata-Corona JC, Juarez-Vega G, Gomez-Martin D, Torres-Ruiz J. Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID). J Gen Intern Med. 2022 Jan;37(1):4-14. doi: 10.1007/s11606-021-07203-8. Epub 2021 Nov 9.
PubMed 34755269
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection
- ClinicalTrials.gov ID
- NCT04367168
- Acronym / sponsor ID
- ColchiVID / 337420-21-1
- Conditions
- COVID
- Keywords
- Colchicine, Coronavirus, Inflammation, Cytokine storm, Clots
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intervention was not effective for the outcomes
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 29 Apr 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.
The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.
Detailed description
This a placebo-controlled double-blind clinical trial to test the efficacy and security of colchicine 1.5 mg at day one followed by 0.5 mg BID to complete 10 days of treatment. The researchers will recruit patients 18-70 years of age who are hospitalized because of the diagnosis of mild or severe COVID-19. Patients will be randomized to receive one of the treatment arms, colchicine or placebo. The aim of the study is to evaluate if colchicine may be able to improve the outcomes in patients with mild and severe COVID-19. Patients will be followed-up during the entire hospitalization time and during convalescence. The importance of this intervention is highlighted because currently, there is not an effective treatment for the virus, nor for the prevention of the cytokine storm or the disseminated intravascular coagulation. Therefore, an early intervention to prevent the development of these complications would be valuable to prevent the morbi-morbidity secondary to severe and critical COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo-controlled clinical trial to test the security and efficacy of colchicine at a dose of 1.5 mg PO at day 1 followed by 0.5 mg PO BID to complete 10 days of treatment
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: ColchicineColchicine PO |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo PO |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Diagnosed with COVID-19 with mild or severe disease
- Who must receive in-hospital care at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Who are able to take pills PO
Key exclusion criteria (1 listed)
- 1. Concomitant participation in another clinical trial. 2. Hypersensitivity to colchicine 3. Pregnancy and lactation 4. Over 70 years 5. Kidney failure with creatinine clearance <30 mL / min. 6. Known liver failure 7. Concomitant medication that has interactions with colchicine and that due to its indication cannot be suspended or substituted
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 |
|---|---|---|
| ColchicineAlso: PerrigoColchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19 | Drug | Colchicine |
| Placebo oral tabletAlso: ArmstrongPlacebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19 | Drug | Placebo |
Primary outcome
Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels
Time frame: Up to 24 days
Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin
Progression to severe disease
Time frame: Up to 10 days
At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg
Results and safety
The study was stopped early (reason given: The intervention was not effective for the outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 34755269Absalon-Aguilar A, Rull-Gabayet M, Perez-Fragoso A, Mejia-Dominguez NR, Nunez-Alvarez C, Kershenobich-Stalnikowitz D, Sifuentes-Osornio J, Ponce-de-Leon A, Gonzalez-Lara F, Martin-Nares E, Montesinos-Ramirez S, Ramirez-Alemon M, Ramirez-Rangel P, Marquez MF, Plata-Corona JC, Juarez-Vega G, Gomez-Martin D, Torres-Ruiz J. Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID). J Gen Intern Med. 2022 Jan;37(1):4-14. doi: 10.1007/s11606-021-07203-8. Epub 2021 Nov 9.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
José J Torres-Ruiz, MD, MSc principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site 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 in people with COVID, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 4 inclusion and 1 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 10 Aug 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 Mexico. 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 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: The intervention was not effective for the outcomes). 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 patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels (time frame: Up to 24 days). 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 NCT04367168, 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 10 Aug 2022.