Clinical trial NCT04435717: Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
timeFrame: Day1 and Day3.
Secondary outcomes:
measure: Progression of pneumonia
timeFrame: Day3, Day7 and Day28
measure: PaO2/FiO2
timeFrame: Day3, Day7 and Day28
measure: cause mortality to 28 days after started treatment
timeFrame: Day3, Day7 and Day28
measure: Length of hospital stay
timeFrame: Day3, Day7 and Day28
measure: patients requiring Intensive Care Unit admission
timeFrame: Day3, Day7 and Day28
measure: evolution of inflammatory parameters IL12
timeFrame: Day0, Day3 and Day7
measure: evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma
timeFrame: Day0, Day3 and Day7
measure: evolution of inflammatory parameters Procalcitonin (PCT),
timeFrame: Day0, Day3 and Day7
measure: evolution of inflammatory parameters C-reactive protein (PCR),
timeFrame: Day0, Day3 and Day7
measure: evolution of inflammatory parameters D-dimer
timeFrame: Day0, Day3 and Day7
measure: evolution of inflammatory parameters and ferritin
timeFrame: Day0, Day3 and Day7
measure: pharmacokinetics of tocilizumab Cmin
timeFrame: Day0, Day1 Day3 and Day7
measure: pharmacokinetics of tocilizumab Cmax
timeFrame: days Day0, Day1 Day3 and Day7
measure: pharmacokinetics of tocilizumab Cmedia
timeFrame: days Day0, Day1 Day3 and Day7
measure: pharmacokinetics of tocilizumab Tmax
timeFrame: days Day0, Day1 Day3 and Day7
measure: pharmacokinetics of tocilizumab AUC
timeFrame: days Day0, Day1 Day3 and Day7
measure: Adverse event
timeFrame: days Day0, Day3, Day7 and Day28
measure: Adverse event to cause the treatment interruption.
timeFrame: days Day0, Day3, Day7 and Day28
measure: Adverse event Abnormalities in laboratory
timeFrame: days Day0, Day3, Day7 and Day28
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: