Trial NCT04332094, EudraCT 2020-001442-19
Publication TOCOVID - TOCOVID, Unpublished (2021) ( )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
Tocilizumab+HCQ/AZM
2x162mg subcutaneously, twice per day for one day
Control
HCQ/AZM

Participants
Randomized
participants :
HCQ/AZM=134
Tocilizumab+HCQ/AZM=136
Characteristics of participants
N= 270
Mean age : NR
167 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
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 willing stated in the publication:

Not reported
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.