Study design and patients
obesity, pneumonia, allergy, renal disease, shortness of breath
OBESITY, DISEASE PROGRESSION, PNEUMONIA, ALLERGY, LIVER DISEASE, RENAL DISEASE
This was a randomized, parallel-group, open-label, multi-center trial. The study protocol was published elsewhere (Male and non-pregnant female patients (18–85 years of age) were eligible and approached by study physicians of the participating centers if they had a diagnostic specimen that was positive for SARS-CoV-2 on reverse-transcriptase–polymerase-chain-reaction (RT-PCR), had pneumonia confirmed by chest imaging, and onset of symptoms ≤10 days or shortness of breath ≤5 days. The latter criterion was adapted/added with an amendment 4 months after approval of the first study protocol, because of the changing patient behaviors over time when seeking for medical help after a positive SARS-CoV-2 test. In addition, at least one of the following risk factors for disease progression was required for enrollment: arterial hypertension, age ≥ 50 years, obesity (BMI ≥ 30.0 kg/mExclusion criteria included refusal to participate, history or suspicion of allergy to rabbits or the study drug, pregnant or breast-feeding individuals, known severe liver disease, and renal disease requiring dialysis. Patients who received tocilizumab or another IL-6 or IL-6 receptor inhibitor prior to enrollment were not eligible for this study. Patients currently requiring intensive care (or expected to do so) within 24 h after initial presentation were not eligible for this study, because “prevention of disease progression” was investigated. Hospitalized patients requiring high-flow oxygen therapy on medical wards were eligible for inclusion.