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

Conditions

Corona Virus Disease 19 (Covid 19)

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.

José Hernández‐Rodríguez, Julio Durán-Sanclemente, Sergio Prieto‐González, Olga Araújo, Teresa Hospital-Vidal et al. (89 authors)

Clinical Drug Investigation2022-09-293 citations

10.1007/s40261-022-01201-2

Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019

Spyridon Deftereos, Γεώργιος Γιαννόπουλος, Dimitrios A. Vrachatis, Gerasimos Siasos, Sotiria G. Giotaki et al. (50 authors)

JAMA Network Open2020-06-24396 citations

10.1001/jamanetworkopen.2020.13136

The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design.

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-Sánchez 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.

2020-01-0199 citations

10.1016/j.hjc.2020.03.002

Use of immunosuppressants/immunomodulators in autoimmune/inflammatory dermatologic diseases during COVID-19 pandemic—General recommendation based on available evidence

Deepika Pandhi, Dipankar De

Indian Dermatology Online Journal2020-01-017 citations

10.4103/idoj.idoj_414_20

Interventions

DRUGColchicine

Low-dose colchicine treatment, 0.5 mg bid

DRUGStandard treatment

Standard treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patient-level randomization scheme

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee	3 weeks	Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
Maximal concentration of cardiac troponin	10 days	Maximal concentration of high-sensitivity cardiac troponin

Countries

Greece

Outcome results

None listed