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

NCT04435717 | Terminated Phase 2

• 1 other identifier: COVITOZ-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Progression of pneumonia

  Day3, Day7 and Day28

• PaO2/FiO2

  Day3, Day7 and Day28

• cause mortality to 28 days after started treatment

  Day3, Day7 and Day28

• Length of hospital stay

  Day3, Day7 and Day28

• patients requiring Intensive Care Unit admission

  Day3, Day7 and Day28

Study Arms (3)

TCZ 8 mg / kg one dose

EXPERIMENTAL

TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment

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

TCZ 8 mg / kg in two

EXPERIMENTAL

TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment

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

standard care treatment

NO INTERVENTION

Usual / standard care treatment

Interventions

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

Tocilizumab 20 MG/ML Intravenous (one dose)

TCZ 8 mg / kg one dose

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

Tocilizumab 20 MG/ML Intravenous ( two doses)

Also known as: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1

TCZ 8 mg / kg in two

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: May 4, 2020
• Primary Completion: November 4, 2020
• Study Completion: February 10, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)