FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities

M. Inzitari | J. Blanco | G. Espinosa | E. Sacanella | G. Casanovas | F. J. Afonso | G. Barilaro | J. Hernández-Rodríguez | S. Prieto-González | J. Calvo | J. Aibar | M. Doménech | G. Doménech | P. Moreno | N. Guasch | A. López-Soto | O. Saavedra | C. García-Gutiérrez | G. Lledó | J. Milisenda | Josep Ortega | R. Ríos-Garcés | M. Tuset | A. Azuaga | A. Capdevila-Reniu | C. Gabara | C. Zamora | I. Grafia | F. Masanés | Maria Joyera | O. Araújo | V. Sapena | C. Cuzco | F. Seguí | K. Cajiao | Ana Matas-García | I. Macaya | Luis Aparicio | M. Pellicé | O. Rodríguez-Núñez | Julio Durán-Sanclemente | Teresa Hospital-Vidal | M. Feliu | H. Ventosa | A. Foncillas | A. Ladino | J. Ribot | B. Gómez | Daniel N Marco | A. San Miguel | Verónica Montes | X. Alemany | Manuel Torres-Elorza | A. Matas-García | Núria Moragas | A. Garcia-Ortega | Verónica Gómez-Caverzaschi | Francisco J. Jesús Xavier Luis Yolanda Anna Ana B. Giuseppe Afonso Aibar Alemany Aparicio Asensio A | Yolanda Asensio | A. Aldea-Parés | Nieves Benages | Maria del Carme Cañueto | Irene Carbonell | Miriam Costafreda | Anna de-Daniel-Bisbe | Alberto Foncillas | Gloria Gámez | Lucía García-Jarque | Vanesa Gómez-Urbano | Tania Gonzalo | M. Guillen | Ana M. Guió | Marta Illa | Irina S. Luzko-Scheid | Néstor López-Guerra | Guillem Masdeu | Miriam I. Mayor | Montse Montero | Marc Montoya-Rodés | Alma Morancho | José Naval | Anna Pahisa | Sona Pilarcikova | Ester Pujol | Elisabet Rivero | Adelaido Salazar | Amparo Sánchez-Buitrago | Víctor Sánchez-Palacios | Ángeles Sanz | Adrià Tomé-Pérez | Roser Ventura | Esther Viñas-Esmel | Daniel N. Marco | J. Naval | A. Sanz | Neus Guasch | I. Grafiá

[1]  D. Sanghavi,et al.  Impact of colchicine on mortality and morbidity in COVID-19: a systematic review , 2022, Annals of medicine.

[2]  E. Pelechas,et al.  Colchicine Against SARS-CoV-2 Infection: What is the Evidence? , 2022, Rheumatology and Therapy.

[3]  F. Saghafi,et al.  Efficacy and safety of colchicine treatment in patients with COVID‐19: A prospective, multicenter, randomized clinical trial , 2022, Phytotherapy research : PTR.

[4]  A. Erden,et al.  Reducing length of hospital stay with colchicine. , 2022, Journal of infection in developing countries.

[5]  Guohui Fan,et al.  The Efficacy and Safety of Janus Kinase Inhibitors for Patients With COVID-19: A Living Systematic Review and Meta-Analysis , 2022, Frontiers in Medicine.

[6]  Miao Li,et al.  Specific Interleukin-1 Inhibitors, Specific Interleukin-6 Inhibitors, and GM-CSF Blockades for COVID-19 (at the Edge of Sepsis): A Systematic Review , 2022, Frontiers in Pharmacology.

[7]  W. M. Raffaello,et al.  Effect of colchicine on mortality in patients with COVID-19 – A systematic review and meta-analysis , 2022, Diabetes & Metabolic Syndrome: Clinical Research & Reviews.

[8]  M. Alsultan,et al.  Efficacy of Colchicine and Budesonide in Improvement Outcomes of Patients with Coronavirus Infection 2019 in Damascus, Syria: A Randomized Control Trial , 2021, Interdisciplinary perspectives on infectious diseases.

[9]  Hui Poh Goh,et al.  The effect of colchicine on mortality outcome and duration of hospital stay in patients with COVID‐19: A meta‐analysis of randomized trials , 2021, Immunity, inflammation and disease.

[10]  W. Adarme-Jaimes,et al.  Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial , 2021, EClinicalMedicine.

[11]  Deepak L. Bhatt,et al.  Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19 , 2021, JAMA network open.

[12]  D. Kershenobich-Stalnikowitz,et al.  Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID) , 2021, Journal of General Internal Medicine.

[13]  J. Ramos-Rincón,et al.  Can we still consider treatment with colchicine effective in SARS-COV-2 infection? Systematic review, meta-analysis, and trial sequential analysis. , 2021, European review for medical and pharmacological sciences.

[14]  I. Chérrez-Ojeda,et al.  Colchicine, COVID‐19 and hematological parameters: A meta‐analysis , 2021, Journal of clinical laboratory analysis.

[15]  N. Skoetz,et al.  Colchicine for the treatment of COVID-19. , 2021, The Cochrane database of systematic reviews.

[16]  D. Cines,et al.  Conflicting impacts of tocilizumab and colchicine in COVID-19-associated coagulop. , 2021, British journal of haematology.

[17]  P. Chavda,et al.  Efficacy and safety of colchicine in COVID-19: a meta-analysis of randomised controlled trials , 2021, RMD Open.

[18]  S. de Lusignan,et al.  Colchicine for COVID-19 in adults in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial , 2021, medRxiv.

[19]  F. Sánchez-Cabo,et al.  Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID) , 2021, International journal of general medicine.

[20]  N. Chiu,et al.  Repurposing Colchicine in Treating Patients with COVID-19: A Systematic Review and Meta-Analysis , 2021, Life.

[21]  Yu Deng,et al.  Association of Hypertension with Severity and Mortality in Hospitalized Patients with COVID-19 in Wuhan, China: A Single-centered, Retrospective Study. , 2021, Arquivos brasileiros de cardiologia.

[22]  M. Mohamed,et al.  Colchicine use might be associated with lower mortality in COVID‐19 patients: A meta‐analysis , 2021, European journal of clinical investigation.

[23]  D. Gaudet,et al.  Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial , 2021, The Lancet Respiratory Medicine.

[24]  Henry Laniado,et al.  Dexamethasone vs methylprednisolone high dose for Covid-19 pneumonia , 2021, PloS one.

[25]  M. Landray,et al.  Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial , 2021, The Lancet Respiratory Medicine.

[26]  R. Pranata,et al.  Colchicine and mortality in patients with coronavirus disease 2019 (COVID-19) pneumonia: A systematic review, meta-analysis, and meta-regression , 2021, International Immunopharmacology.

[27]  U. Maggiore,et al.  Reduced mortality in COVID-19 patients treated with colchicine: Results from a retrospective, observational study , 2021, PloS one.

[28]  A. Kurniawan,et al.  Colchicine treatment can improve outcomes of coronavirus disease 2019 (COVID‐19): A systematic review and meta‐analysis , 2021, Clinical and experimental pharmacology & physiology.

[29]  S. Matskeplishvili,et al.  Proactive anti-inflammatory therapy with colchicine in the treatment of advanced stages of new coronavirus infection. The first results of the COLORIT study. , 2021, Kardiologiia.

[30]  Thomas A. Jackson,et al.  Age and frailty are independently associated with increased COVID-19 mortality and increased care needs in survivors: results of an international multi-centre study , 2021, Age and ageing.

[31]  Rahul Aggarwal,et al.  Colchicine use in patients with COVID-19: A systematic review and meta-analysis , 2021, medRxiv.

[32]  F. Cunha,et al.  Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial , 2021, RMD Open.

[33]  M. Moghadami,et al.  Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial , 2021, BMC Infectious Diseases.

[34]  E. Figueroa,et al.  Early use of corticosteroids in non-critical patients with COVID-19 pneumonia (PREDCOVID): a structured summary of a study protocol for a randomised controlled trial , 2021, Trials.

[35]  C. Riccardi,et al.  A Glance at the Use of Glucocorticoids in Rare Inflammatory and Autoimmune Diseases: Still an Indispensable Pharmacological Tool? , 2021, Frontiers in Immunology.

[36]  Monireh Golpour,et al.  The effectiveness of Colchicine as an anti-inflammatory drug in the treatment of coronavirus disease 2019: Meta-analysis , 2021, International journal of immunopathology and pharmacology.

[37]  Kehua Guo,et al.  A predictive model for the severity of COVID-19 in elderly patients , 2020, Aging.

[38]  M. Pinzón,et al.  Clinical outcome of patients with COVID-19 Pneumonia treated with corticosteroids and colchicine in Colombia , 2020, Annals of clinical microbiology and antimicrobials.

[39]  S. Chilimuri,et al.  A Case Control Study to Evaluate the Impact of Colchicine on Patients Admitted to the Hospital with Moderate to Severe COVID-19 Infection , 2020, The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale.

[40]  Arthur S Slutsky,et al.  Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. , 2020, JAMA.

[41]  B. Firestein,et al.  Colchicine to Weather the Cytokine Storm in Hospitalized Patients with COVID-19 , 2020, Journal of clinical medicine.

[42]  M. Cotelli,et al.  Association between treatment with colchicine and improved survival in a single-centre cohort of adult hospitalised patients with COVID-19 pneumonia and acute respiratory distress syndrome , 2020, Annals of the Rheumatic Diseases.

[43]  G. Ruiz-Irastorza,et al.  Second week methyl-prednisolone pulses improve prognosis in patients with severe coronavirus disease 2019 pneumonia: An observational comparative study using routine care data , 2020, medRxiv.

[44]  anonymous.  WHO WELCOMES PRELIMINARY RESULTS ABOUT DEXAMETHASONE USE IN TREATING CRITICALLY ILL COVID -19 PATIENTS , 2020, Saudi Medical Journal.

[45]  R. Manna,et al.  Current Therapeutic Options for the Main Monogenic Autoinflammatory Diseases and PFAPA Syndrome: Evidence-Based Approach and Proposal of a Practical Guide , 2020, Frontiers in Immunology.

[46]  G. Dangas,et al.  Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019 , 2020, JAMA network open.

[47]  L. Dagna,et al.  Treating COVID-19 with colchicine in community healthcare setting , 2020, Clinical Immunology.

[48]  L. Andreoli,et al.  Why not to use colchicine in COVID-19? An old anti-inflammatory drug for a novel auto-inflammatory disease , 2020, Rheumatology.

[49]  N. Ortego Centeno,et al.  Effectiveness of corticoid pulses in patients with cytokine storm syndrome induced by SARS-CoV-2 infection. , 2020, Medicina clinica.

[50]  J. L. Callejas Rubio,et al.  Eficacia de los pulsos de corticoides en pacientes con síndrome de liberación de citocinas inducido por infección por SARS-CoV-2 , 2020, Medicina Clínica.

[51]  M. González-Gay,et al.  Tocilizumab: from the rheumatology practice to the fight against COVID-19, a virus infection with multiple faces , 2020, Expert opinion on biological therapy.

[52]  J. Hartwell,et al.  Silencing the cytokine storm: the use of intravenous anakinra in haemophagocytic lymphohistiocytosis or macrophage activation syndrome , 2020, The Lancet Rheumatology.

[53]  Eun Ji Kim,et al.  Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. , 2020, JAMA.

[54]  Ke Liang,et al.  Clinical characteristics and outcomes of older patients with coronavirus disease 2019 (COVID-19) in Wuhan, China (2019): a single-centered, retrospective study , 2020, The journals of gerontology. Series A, Biological sciences and medical sciences.

[55]  P. Mehta,et al.  COVID-19: consider cytokine storm syndromes and immunosuppression , 2020, The Lancet.

[56]  J. Xiang,et al.  Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study , 2020, The Lancet.

[57]  Honglu Liu,et al.  Inhibition of respiratory syncytial virus replication and suppression of RSV-induced airway inflammation in neonatal rats by colchicine , 2019, 3 Biotech.

[58]  Charalampos Kossyvakis,et al.  Colchicine Pharmacokinetics and Mechanism of Action. , 2018, Current pharmaceutical design.

[59]  P. Barnes,et al.  Anti-inflammatory actions of glucocorticoids: molecular mechanisms. , 1998, Clinical science.

[60]  W. Jusko,et al.  Oral Absorption Characteristics and Pharmacokinetics of Colchicine in Healthy Volunteers after Single and Multiple Doses , 1996, Journal of clinical pharmacology.

[61]  M E Pickup,et al.  Clinical Pharmacokinetics of Prednisone and Prednisolone , 1979, Clinical pharmacokinetics.

[62]  W. Lim,et al.  Dexamethasone in Hospitalized Patients with Covid-19 , 2021 .