Clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19

Phase 1

• Conditions: on-severe pneumonia caused by COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002032-69-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-05
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Patients over 18 years old and under 80 years old who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigator.
2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically =7 days before randomization, and presents:
a. Basal oxygen saturation> 90%
b. IL-6 levels> 40 pg / ml
c. CURB-65 =1
d. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified