Trial *
Publication Guaraldi G, Lancet Rheumatol, 2020
Dates: 2020-02-21 to 2020-04-30
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / Italy Follow-up duration (days): 14 | |
| Inclusion criteria | The study population was adults (≥18 years) with COVID-19, confirmed by PCR on nasopharyngeal swab, who were admitted to the centres in Bologna and Reggio Emilia between Feb 21 and March 24, 2020, and to the centre in Modena between Feb 21 and April 30, 2020 (after reviewers requested a follow-up extension, which was only possible at the Modena centre). Eligible patients had severe pneumonia, defined as at least one of the following: presence of a respiratory rate of 30 or more breaths per minute, peripheral blood oxygen saturation (SaO2) of less than 93% in room air, a ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) of less than 300 mm Hg in room air, and lung infiltrates of more than 50% within 24–48 h, according to Chinese management guidelines for COVID-19 (version 6.0) |
| Exclusion criteria | Exclusion criteria for the use of tocilizumab were coexistent infection other than COVID-19; a PaO2/FiO2 ratio greater than 300 mm Hg; chronic or current glucocorticoid use; history of severe allergic reactions to monoclonal antibodies; less than 500 per μL neutrophils or less than 50 × 10⁹ platelets; active diverticulitis, inflammatory bowel disease, or another symptomatic gastrointestinal tract condition that might predispose patients to bowel perforation; severe haematological, renal, or liver function impairment. |
| Type of analysis | Multivariable Cox Regression |
| Interventions | |
| Treatment
Tocilizumab (8 mg/kg body weight ) Co-Intervention: Standard care Duration : 1 day |
|
| Control
Standard care Definition of Standard care: Standard of care treatment included oxygen supply to target SaO2 reaching at least 90%, hydroxychloroquine (400 mg twice on day 1, followed by 200 mg twice per day on days 2–5, eventually adjusted for creatinine clearance estimated by a chronic kidney disease algorithm), azithromycin (500 mg once per day for 5 days) at the physician’s discretion when suspecting a bacterial respiratory superinfection, lopinavir–ritonavir (400/100 mg twice per day) or darunavir–cobicistat (800/150 mg once per day) for 14 days, and low molecular weight heparin for prophylaxis of deep vein thrombosis according to bodyweight and renal function. Duration : 14 days | |
| Participants | |
| N analyzed 544 participants (n1=179 / n2= 365) | |
| Characteristics of participants N=* Mean age : NR 359 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=544 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report The primary outcome of the study was a composite of death or invasive mechanical ventilation | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated NR |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
* |
| Notes |