unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
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.
Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
Tocilizumab 20 MG/ML Intravenous (one dose)
Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
Tocilizumab 20 MG/ML Intravenous ( two doses)
Other Name: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
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.
Hospital Universitario Ramón y Cajal
Madrid, Spain