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

Covid19 Clinical Trial

— COVITOZ-01  

Official title:

Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04435717
• Other study ID #: COVITOZ-01
• Status: Terminated
• Phase: Phase 2
• Start date: May 4, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: August 2021
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: February 10, 2021
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
Tocilizumab 20 MG/ML Intravenous (one dose)
• Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
Tocilizumab 20 MG/ML Intravenous ( two doses)

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.	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.	Day1 and Day3.
Secondary	Progression of pneumonia	Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28	Day3, Day7 and Day28
Secondary	PaO2/FiO2	Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 =315) at some point in the evolution.	Day3, Day7 and Day28
Secondary	cause mortality to 28 days after started treatment	cause mortality to 28 days after started treatment	Day3, Day7 and Day28
Secondary	Length of hospital stay	Length of hospital stay	Day3, Day7 and Day28
Secondary	patients requiring Intensive Care Unit admission	Percentage of patients requiring Intensive Care Unit admission	Day3, Day7 and Day28
Secondary	evolution of inflammatory parameters IL12	IL-12 levels at Day 7	Day0, Day3 and Day7
Secondary	evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma	IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7	Day0, Day3 and Day7
Secondary	evolution of inflammatory parameters Procalcitonin (PCT),	Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7; 7	Day0, Day3 and Day7
Secondary	evolution of inflammatory parameters C-reactive protein (PCR),	C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7; 7	Day0, Day3 and Day7
Secondary	evolution of inflammatory parameters D-dimer	D-dimer levels on days Day0, Day1, Day3 and Day 7; 7	Day0, Day3 and Day7
Secondary	evolution of inflammatory parameters and ferritin	ferritin levels on days Day0, Day1, Day3 and Day 7; 7	Day0, Day3 and Day7
Secondary	pharmacokinetics of tocilizumab Cmin	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.	Day0, Day1 Day3 and Day7
Secondary	pharmacokinetics of tocilizumab Cmax	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.	days Day0, Day1 Day3 and Day7
Secondary	pharmacokinetics of tocilizumab Cmedia	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.	days Day0, Day1 Day3 and Day7
Secondary	pharmacokinetics of tocilizumab Tmax	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.	days Day0, Day1 Day3 and Day7
Secondary	pharmacokinetics of tocilizumab AUC	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.	days Day0, Day1 Day3 and Day7
Secondary	Adverse event	Serious and non-serious adverse events.	days Day0, Day3, Day7 and Day28
Secondary	Adverse event to cause the treatment interruption.	Adverse events to cause the treatment interruption.	days Day0, Day3, Day7 and Day28
Secondary	Adverse event Abnormalities in laboratory	Abnormalities in laboratory findings unrelated to COVID-19 disease.	days Day0, Day3, Day7 and Day28