Clinical trial NCT04326790: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Official title: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Corona Virus Disease 19 (Covid 19)
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-level randomization scheme
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
timeFrame: 3 weeks
measure: Maximal concentration of cardiac troponin
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.