Corona Virus Disease 19 (Covid 19)Phase 2GRECCO-19NCT04326790
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
A Phase 2 study testing Colchicine and Standard treatment in people with Corona Virus Disease 19 (Covid 19), run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Disease 19 (Covid 19)
- What is being tested?
- Colchicine and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGreece
- Study dates
- 3 Apr 2020to 27 Apr 2020
- 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
- Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg.
Who cannot join
- pregnancy, lactation;
- known hypersensitivity to colchicine
- known hepatic failure
- eGFR<20 ml/min
- clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
- any clinical estimation of the attending physician under which the patient shall be excluded
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- QTc > 450 msec (colchicine is not known to significantly prolong QTc, but may interact with other medications which prolong QTc).
- participation in another clinical trial
- under colchicine treatment for other indications
- patient who is not likely to comply to study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.
- Conditions
- Corona Virus Disease 19 (Covid 19)
- Being tested
- Colchicine, Standard treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Low-dose colchicine treatment, 0.5 mg bid
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Colchicine, on top of standard treatment Receives: Drug: Colchicine; Drug: Standard treatment |
| Control | Active comparator | Standard treatment, including all medications recommedned by the National Public Health Organization Receives: Drug: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
Time to clinical deterioration (2 levels in the WHO R\&D Blueprint scale)
Measured: 3 weeks
Maximal concentration of cardiac troponin
Maximal concentration of high-sensitivity cardiac troponin
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start3 Apr 2020
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Why it stopped: Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corona Virus Disease 19 (Covid 19)Studies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Patient-level randomization scheme
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyridon Deftereos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326790
- Sponsor's protocol ID
- 906295542
- Acronym
- GRECCO-19
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mikolajewska 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 34658014Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinez-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.
PubMed 32579195Deftereos SG, Siasos G, Giannopoulos G, Vrachatis DA, Angelidis C, Giotaki SG, Gargalianos P, Giamarellou H, Gogos C, Daikos G, Lazanas M, Lagiou P, Saroglou G, Sipsas N, Tsiodras S, Chatzigeorgiou D, Moussas N, Kotanidou A, Koulouris N, Oikonomou E, Kaoukis A, Kossyvakis C, Raisakis K, Fountoulaki K, Comis M, Tsiachris D, Sarri E, Theodorakis A, Martinez-Dolz L, Sanz-Sanchez J, Reimers B, Stefanini GG, Cleman M, Filippou D, Olympios CD, Pyrgakis VN, Goudevenos J, Hahalis G, Kolettis TM, Iliodromitis E, Tousoulis D, Stefanadis C. The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design. Hellenic J Cardiol. 2020 Jan-Feb;61(1):42-45. doi: 10.1016/j.hjc.2020.03.002. Epub 2020 Apr 3.
PubMed 32251729
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
- ClinicalTrials.gov ID
- NCT04326790
- Acronym / sponsor ID
- GRECCO-19 / 906295542
- Conditions
- Corona Virus Disease 19 (Covid 19)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 30 Mar 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.
Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient-level randomization scheme
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Colchicine, Drug: Standard treatmentColchicine, on top of standard treatment |
| Control | Active comparator | Drug: Standard treatmentStandard treatment, including all medications recommedned by the National Public Health Organization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg.
Key exclusion criteria (10 listed)
- pregnancy, lactation;
- known hypersensitivity to colchicine
- known hepatic failure
- eGFR<20 ml/min
- clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
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 |
|---|---|---|
| ColchicineLow-dose colchicine treatment, 0.5 mg bid | Drug | Intervention |
| Standard treatmentStandard treatment | Drug | Control, Intervention |
Primary outcome
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
Time frame: 3 weeks
Time to clinical deterioration (2 levels in the WHO R\&D Blueprint scale)
Maximal concentration of cardiac troponin
Time frame: 10 days
Maximal concentration of high-sensitivity cardiac troponin
Results and safety
The study was stopped early (reason given: Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- 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.
- Derived from this study: PubMed 32579195Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinez-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.
- Derived from this study: PubMed 32251729Deftereos SG, Siasos G, Giannopoulos G, Vrachatis DA, Angelidis C, Giotaki SG, Gargalianos P, Giamarellou H, Gogos C, Daikos G, Lazanas M, Lagiou P, Saroglou G, Sipsas N, Tsiodras S, Chatzigeorgiou D, Moussas N, Kotanidou A, Koulouris N, Oikonomou E, Kaoukis A, Kossyvakis C, Raisakis K, Fountoulaki K, Comis M, Tsiachris D, Sarri E, Theodorakis A, Martinez-Dolz L, Sanz-Sanchez J, Reimers B, Stefanini GG, Cleman M, Filippou D, Olympios CD, Pyrgakis VN, Goudevenos J, Hahalis G, Kolettis TM, Iliodromitis E, Tousoulis D, Stefanadis C. The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design. Hellenic J Cardiol. 2020 Jan-Feb;61(1):42-45. doi: 10.1016/j.hjc.2020.03.002. Epub 2020 Apr 3.
- Individual participant dataSharing planned: Undecided
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 2 study testing Colchicine and Standard treatment in people with Corona Virus Disease 19 (Covid 19), run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 inclusion and 10 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 6 Apr 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 Greece. 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: Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece). 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?
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee (time frame: 3 weeks). 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 NCT04326790, which also lists 3 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 6 Apr 2021.