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

Madrid Health Service

Status and phase: Terminated; Phase 2

Conditions: Covid19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04435717

COVITOZ-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

TCZ 8 mg / kg one dose

Experimental group

Description:

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

Treatment:

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

TCZ 8 mg / kg in two

Experimental group

Description:

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

Treatment:

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

standard care treatment

No Intervention group

Description:

Usual / standard care treatment