The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention (GRECCO-19)

• ClinicalTrials.gov Identifier: NCT04326790
• Recruitment Status: Terminated
• First Posted: March 30, 2020
• Last Update Posted: April 6, 2021
• Sponsor: National and Kapodistrian University of Athens
• Information provided by (Responsible Party): Spyridon Deftereos, National and Kapodistrian University of Athens

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Corona Virus Disease 19 (Covid 19)	Drug: Colchicine; Drug: Standard treatment	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patient-level randomization scheme
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
• Actual Study Start Date: April 3, 2020
• Actual Primary Completion Date: April 27, 2020
• Actual Study Completion Date: April 27, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Colchicine, on top of standard treatment	Drug: Colchicine; Low-dose colchicine treatment, 0.5 mg bid; Drug: Standard treatment; Standard treatment
Active Comparator: Control; Standard treatment, including all medications recommedned by the National Public Health Organization	Drug: Standard treatment; Standard treatment

Outcome Measures

Primary Outcome Measures :

1. 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)
2. Maximal concentration of cardiac troponin [ Time Frame: 10 days ]
   Maximal concentration of high-sensitivity cardiac troponin

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

• 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
• 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

Contacts and Locations

Locations

Greece

National and Kapodistrian University of Athens

Athens, Greece

Sponsors and Collaborators

National and Kapodistrian University of Athens

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Deftereos 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.

Deftereos 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.

• Responsible Party: Spyridon Deftereos, Professor of Cardiology, National and Kapodistrian University of Athens
• ClinicalTrials.gov Identifier: NCT04326790
• Other Study ID Numbers: 906295542
• First Posted: March 30, 2020
• Last Update Posted: April 6, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Virus Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Colchicine; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents