Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
- Provide oral informed consent to participate in this study.
- At least 18 years of age.
- Diagnosed with COVID-19 pneumonia by RT-PCR.
- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment
- Hospitalized or admitted to ICU
Exclusion Criteria:
- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient's safety or collected data
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Active acute and severe infections, including tuberculosis infection
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Sites / Locations
- Hospital Universitario de Cabueñes
- Hospital Universitari de Bellvitge
- Hospital Sant Joan de Déu de Manresa
- Hospital de Mataró
- Hospital Universitario de Galdakao
- Hospital Universitario Marqués Valdecilla
- Hospital Público General del Tomelloso
- Hospital Jerez de la Frontera
- Hospital Universitari Son Espases
- Hospital Universitario Fundación Alcorcón
- Hospital Universitario de Fuenlabrada
- Hospital Universitario de Getafe
- Hospital Rey Juan Carlos
- Hospital Universitario Rey Juan Carlos
- Hospital Universitario Infanta Sofía
- Complejo Hospitalario de Navarra
- Hospital Nuestra Señora del Prado
- Complejo Hospitalario Universitario de Albacete
- Hospital Infanta Cristina
- Hospital Clínic i Provincial Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario de Burgos
- Hospital Universitario Dr. Josep Trueta
- Hospital Universitario Clínico San Cecilio
- Hospital Universitario Virgen de las Nieves
- Hospital General Universitario Gregorio Marañón
- Hospital Universitario Fundación Jiménez Díaz
- Hospital Universitario HM Sanchinarro
- Hospital Universitario Infanta Leonor
- Hospital Universitario Ramón y Cajal
- Hospital Clínico Universitario Virgen de la Arrixaca
- Hospital Regional Universitario de Málaga
- Complexo Hospitalario Universitario de Ourense
- Hospital Universitario Salamanca
- Hospital Universitario Virgen de la Macarena
- Hospital Universitario Virgen del Rocío
- Hospital Virgen de la Salud
- Hospital Clinico Universitario de Valencia
- Hospital Universitari i Poliectenic La Fe
- Hospital Universitario Dr. Peset
- Hospital Clínico Universitario Lozano Blesa
- Hospital Universitario Miguel Servet
Arms of the Study
Arm 1
Experimental
Tocilizumab
Patients will receive IV tocilizumab as per clinical practice and at the discretion of treating investigator, following the posology indicated in the SmPC, or the recommendations proposed by the Spanish Ministry of Health: The recommended posology by the SmPC is 8 mg per kg in patients weighing greater than or equal to 30 kg or 12 mg per kg in patients weighing less than 30 kg. If no clinical improvement in the signs and symptoms up to 3 additional doses of tocilizumab may be administered. The interval between consecutive doses should be at least 8 hours. The recommendations of the Spanish Ministry of Health: Patients more than 80 kg: first dose 600 mg; second dose 600 mg. Patients less than 80 kg: first dose 600 mg; second dose 400 mg. A third dose might be considered 16 to 24 hours after if: fever persists or a worsening of the laboratory parameters Given the exceptionality of the situation modification of doses according to the physician experience will be allowed.