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

Phase 2TerminatedNCT04435717

Hospital Universitario Ramon y Cajal26 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1DRUG

Tocilizumab 20 MG/ML Intravenous (one dose)

Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)DRUG

Tocilizumab 20 MG/ML Intravenous ( two doses)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Ramón y Cajal

Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: Day1 and Day3.