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

• Status: Terminated
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Ramon y Cajal
• Treatments: Pharmaceutical Solutions

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.