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Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) (COVITOZ-01)

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ClinicalTrials.gov Identifier: NCT04435717
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jose A Perez Molina, Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE June 11, 2020
First Posted Date  ICMJE June 17, 2020
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE May 4, 2020
Estimated Primary Completion Date August 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2020)
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3. [ Time Frame: Day1 and Day3. ]
Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2020)
  • Progression of pneumonia [ Time Frame: Day3, Day7 and Day28 ]
    Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28
  • PaO2/FiO2 [ Time Frame: Day3, Day7 and Day28 ]
    Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.
  • cause mortality to 28 days after started treatment [ Time Frame: Day3, Day7 and Day28 ]
    cause mortality to 28 days after started treatment
  • Length of hospital stay [ Time Frame: Day3, Day7 and Day28 ]
    Length of hospital stay
  • patients requiring Intensive Care Unit admission [ Time Frame: Day3, Day7 and Day28 ]
    Percentage of patients requiring Intensive Care Unit admission
  • evolution of inflammatory parameters IL12 [ Time Frame: Day0, Day3 and Day7 ]
    IL-12 levels at Day 7
  • evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma [ Time Frame: Day0, Day3 and Day7 ]
    IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7
  • evolution of inflammatory parameters Procalcitonin (PCT), [ Time Frame: Day0, Day3 and Day7 ]
    Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7
    • 7
  • evolution of inflammatory parameters C-reactive protein (PCR), [ Time Frame: Day0, Day3 and Day7 ]
    C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7
    • 7
  • evolution of inflammatory parameters D-dimer [ Time Frame: Day0, Day3 and Day7 ]
    D-dimer levels on days Day0, Day1, Day3 and Day 7
    • 7
  • evolution of inflammatory parameters and ferritin [ Time Frame: Day0, Day3 and Day7 ]
    ferritin levels on days Day0, Day1, Day3 and Day 7
    • 7
  • pharmacokinetics of tocilizumab Cmin [ Time Frame: Day0, Day1 Day3 and Day7 ]
    Cmin,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
  • pharmacokinetics of tocilizumab Cmax [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Cmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
  • pharmacokinetics of tocilizumab Cmedia [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Cmedia,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
  • pharmacokinetics of tocilizumab Tmax [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Tmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
  • pharmacokinetics of tocilizumab AUC [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    AUC,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
  • Adverse event [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Serious and non-serious adverse events.
  • Adverse event to cause the treatment interruption. [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Adverse events to cause the treatment interruption.
  • Adverse event Abnormalities in laboratory [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Abnormalities in laboratory findings unrelated to COVID-19 disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)
Official Title  ICMJE Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
Brief Summary unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
Detailed Description

National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.

The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.

78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Patients eligible to be included in the study will be randomized in a 1: 1: 1 ratio to receive:

  • TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
  • TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
  • Usual / standard care treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
    Tocilizumab 20 MG/ML Intravenous (one dose)
  • Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
    Tocilizumab 20 MG/ML Intravenous ( two doses)
    Other Name: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
Study Arms  ICMJE
  • Experimental: TCZ 8 mg / kg one dose
    TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
    Intervention: Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
  • Experimental: TCZ 8 mg / kg in two
    TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
    Intervention: Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
  • No Intervention: standard care treatment
    Usual / standard care treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2020)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 4, 2020
Estimated Primary Completion Date August 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
  2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:

    to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315

  3. The patient is hospitalized or meets hospital admission criteria.
  4. The patient is not expected to enter the ICU or die in the next 24 hours.

Exclusion Criteria:

  1. Participants in another simultaneous clinical trial.
  2. Use of other immunomodulators.
  3. Coinfection with the hepatitis B virus (detectable AgSup-HBV).
  4. Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
  5. Presence of laboratory abnormalities of grade ≥ 4.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose A Perez-Molina, PhD +34913368108 jperezm@salud.madrid.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04435717
Other Study ID Numbers  ICMJE COVITOZ-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jose A Perez Molina, Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Ramon y Cajal
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP