A study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia
Genentech
Abstract
Condition: COVID-19 pneumonia, COVID-19 (SARS-CoV-2 infection) Respiratory COVID-19 pneumonia, COVID-19 (SARS-CoV-2 infection) Intervention: To assess long-term outcomes in adult patients who were hospitalized with COVID-19 associated pneumonia. Participants will be recruited from Genentech/Roche sponsored studies or any supported Genentech/Roche independent investigator studies for COVID-19 associated pneumonia. Participants will be followed up for pulmonary, cardiac, cognitive, and quality of life outcomes every three months over 12 months. In addition, any encounters with health care professionals/visits at health care facilities outside of the visits scheduled within the study will be recorded. Primary outcome: 1. Lung texture analysis of high-resolution computed tomography (HRCT) scan of the chest at baseline, 3, 6, 9, and 12 months 2. Lung function measured using pulmonary function tests at baseline, 3, 6, 9, and 12 months 3. Cardiac function measured using echocardiography at baseline, 3, 6, 9, and 12 months 4. Healthcare resource utilization measured using hospitalization, emergency room visits, urgent care/unscheduled visits, physical therapy, and rehabilitation, in addition to other relevant information collected betweenbaseline, 3, 6, 9, and 12 months 5. Patient-reported health-related quality of life, cognitive function, and respiratory symptoms, measured by the Short Form 36 Question Health Survey Version 2 (SF-36v2), Euro-QoL-5D-5-L (EQ-5D-5L), Living with Idiopathic Pulmonary Fibrosis Symptoms Questionnaire-Modified (L-IPF-M), and Montreal Cognitive Assessment (MoCA) at baseline, 3, 6, 9, and 12 months Criteria: Inclusion criteria: 1. Informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by their legal/authorized representative 2. Aged =18 years at the time of providing informed consent 3. Able to comply with the study procedures, in the investigator's judgment 4. Participated in any Genentech/Roche sponsored study or any supported Genentech/Roche independent investigator study for COVID-19 associated pneumonia (Note: Includes patients who completed or discontinued early from these studies) Exclusion criteria: 1. Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study 2. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study