TY - JOUR
T1 - TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol
AU - Piccirillo, Maria Carmela
AU - Ascierto, Paolo
AU - Atripaldi, Luigi
AU - Cascella, Marco
AU - Costantini, Massimo
AU - Dolci, Giovanni
AU - Facciolongo, Nicola
AU - Fraganza, Fiorentino
AU - Marata, Anna Maria
AU - Massari, Marco
AU - Montesarchio, Vincenzo
AU - Mussini, Cristina
AU - Negri, Emanuele Alberto
AU - Parrella, Roberto
AU - Popoli, Patrizia
AU - Botti, Gerardo
AU - Arenare, Laura
AU - Chiodini, Paolo
AU - Gallo, Ciro
AU - Salvarani, Carlo
AU - Perrone, Francesco
PY - 2020/11
Y1 - 2020/11
N2 - Background: Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor. Methods: This multicentre study project includes a single-arm phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air ≤93% or requiring respiratory support. Patients receive tocilizumab 8 mg/kg (up to 800 mg) as one intravenous administration. A second administration (same dose) after 12 h is optional. Two-week and one-month lethality rates are the co-primary endpoints. Sample size planned for the phase 2 study is 330 patients. The parallel cohort will include patients who cannot enter the phase 2 study because being intubated from more than 24 h, or having already received tocilizumab, or the phase 2 study has reached sample size. Primary analysis will include patients enrolled in the phase 2 study. Results of the primary analysis will be validated in the prospective cohort of patients consecutively registered after phase 2 closure from March 20 to March 24, who were potentially eligible for the phase 2 study. Conclusion: This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. EudraCT Number: 2020–001110-38; Clinicaltrials.gov ID NCT04317092
AB - Background: Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor. Methods: This multicentre study project includes a single-arm phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air ≤93% or requiring respiratory support. Patients receive tocilizumab 8 mg/kg (up to 800 mg) as one intravenous administration. A second administration (same dose) after 12 h is optional. Two-week and one-month lethality rates are the co-primary endpoints. Sample size planned for the phase 2 study is 330 patients. The parallel cohort will include patients who cannot enter the phase 2 study because being intubated from more than 24 h, or having already received tocilizumab, or the phase 2 study has reached sample size. Primary analysis will include patients enrolled in the phase 2 study. Results of the primary analysis will be validated in the prospective cohort of patients consecutively registered after phase 2 closure from March 20 to March 24, who were potentially eligible for the phase 2 study. Conclusion: This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. EudraCT Number: 2020–001110-38; Clinicaltrials.gov ID NCT04317092
KW - COVID-19 pneumonia
KW - Phase 2 study
KW - Tocilizumab
UR - http://www.scopus.com/inward/record.url?scp=85092201362&partnerID=8YFLogxK
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U2 - 10.1016/j.cct.2020.106165
DO - 10.1016/j.cct.2020.106165
M3 - Article
AN - SCOPUS:85092201362
VL - 98
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106165
ER -