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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2021-02-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCZ 8 mg / kg one dose

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Tocilizumab 20 MG/ML Intravenous (one dose)

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Tocilizumab 20 MG/ML Intravenous ( two doses)

standard care treatment

Usual / standard care treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Tocilizumab 20 MG/ML Intravenous (one dose)

Intervention Type DRUG

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

Tocilizumab 20 MG/ML Intravenous ( two doses)

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No