Non-severe pneumonia caused by COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: RoActemra
Product Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Co
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of administering two different tocilizumab regimens versus the standard of care on IL-12 levels in patients with non-severe COVID-19 pneumonia.;Secondary Objective: 1. To evaluate and compare the clinical course and mortality of the patients assigned to the three treatment groups. 2. To evaluate and compare other inflammatory parameters and their changes over time in patients assigned to the three treatment groups. 3. To assess the safety of tocilizumab treatment for mild-to-moderate COVID-19 pneumonia. 4. To evaluate and compare pharmacokynetics of tocilizumab based on regimens administered;Primary end point(s): Mean increase in IL-12 levels in the 3 study groups from the start of treatment (D0) to days D+1 and D+3. A mean difference >0.2 units between any of the three study groups will be considered a significant response in terms of IL-12 levels.;Timepoint(s) of evaluation of this end point: Day 0, day +1 and Day +3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients per group with cure/improvement/progression of pneumonia at D+3, D+7, and D+28. • Proportion of patients with PaO2/FiO2 <300 (or SatO2/FiO2 =315) at some point over their course. • All-cause mortality throughout 28 days. • Length of hospital stay. • Percentage of patients requiring ICU admission. • Length of ICU stay. • IL-12 levels at D+7 • IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels at D0, D+1, D+3 and D+7 • IL-6, procalcitonin (PCT), C-reactive protein (CRP), D-dimer y ferritin levels at D0, D+1, D+3 and D+7. • Pharmacokinetic endpoints: Cmin, Cmax, Cmedia, Tmax and AUC on days D0, D + 1, D + 3 and D + 7. • Serious and non-serious adverse events. • Adverse events leading to treatment discontinuation. • Number of deaths. • Abnormalities in laboratory findings unrelated to COVID-19 disease.;Timepoint(s) of evaluation of this end point: Day 0, day +1, day +3, day +7, day +28. | — |
Countries
Spain
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic Science S.L.
Outcome results
None listed