Trial NCT04435717
Publication COVITOZ-01 - COVITOZ-01, Unpublished (2021) (unpublished results)
Dates: 2020-05-04 to 2020-10-21
Funding: Public/non profit (Hospital Universitario Ramon y Cajal)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Single center / Spain
Follow-up duration (days): 90
Inclusion criteria
  • Patients over 18 years of age who have given their informed consent
  • The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents: Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
  • The patient is hospitalized or meets hospital admission criteria
  • The patient is not expected to enter the ICU or die in the next 24 hours.
Exclusion criteria
  • Participants in another simultaneous clinical trial
  • Use of other immunomodulators
  • Coinfection with the hepatitis B virus (detectable AgSup-HBV)
  • Pregnancy (or planning to become pregnant during the course of the study), or lactation period
  • Presence of laboratory abnormalities of grade ≥ 4.
Interventions
Treatment
Tocilizumab
8mg/kg (max 800mg) IV single dose OR two doses
Control
Standard care

Participants
Randomized
participants :
Standard care=9
Tocilizumab=17
Characteristics of participants
N= 26
Mean age : NR
17 males
Severity : Mild: n=9 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
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 yet published. 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.
COVITOZ-01 study was terminated for futility reasons with actual enrollment (26/78) being 33% of the planned sample size.