Trial NCT04435717
Publication COVITOZ-01, Unpublished, 2021 ( )
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
Standard care * |
|
Control
Tocilizumab ( / ) | |
Participants | |
Randomized 26 participants (n1=9 / n2= 17) | |
Characteristics of participants N=26 Mean age : NR 17 males Severity : Mild: n=9 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
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 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 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. |