Trial NCT04332094, EudraCT 2020-001442-19
Publication TOCOVID, Unpublished, 2021 ( )
Dates: 2020-04-02 to 2021-02-27
Funding: Public/non profit (Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau)
Conflict of interest: *
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Spain Follow-up duration (days): 90 | |
Inclusion criteria | Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure; Understand and agree to abide by the study procedures; Adult ≥ 18 years of age at the time of inclusion in the study; Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours; Severity 3-4 according to the WHO 7-point ordinal scale. |
Exclusion criteria | ALT / AST> 5 times the normal limit; Stage 4 chronic kidney disease (GFR <30) or requiring dialysis; Presence of comorbidities that imply a poor prognosis (according to clinical judgment); Advanced dementia; Pregnancy or breastfeeding; Anticipation of transfer to another center in the 12 hours at the beginning of the study; Allergy to study medication; Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2; Streptococcus pneumoniae antigenuria positive before study start; Neutropenia <500 / mm3; Thrombocytopenia <100,000 / mm3; History of diverticulosis; Ongoing skin infection (eg, pyodermitis); Transplanted patient under immunosuppressive treatment; Previous evidence of latent untreated tuberculosis. |
Interventions | |
Treatment
Standard care * |
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Control
Tocilizumab ( / ) | |
Participants | |
Randomized 270 participants (n1=134 / n2= 136) | |
Characteristics of participants N=270 Mean age : NR 167 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register In-hospital mortality [ Time Frame: Through hospitalization, an average of 2 weeks ] | |
In the report NR | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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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 |
Low |
General comment | The study is not published yet. Data presented was extracted from study registry and The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499–518. The authors have been contacted in order to obtain the results. |