We enrolled 987 patients with proven life-threatening (critical) COVID-19, 663 asymptomatic or pauci-symptomatic individuals with proven COVID-19, and 1227 healthy controls in this study. All subjects were recruited following protocols approved by local Institutional Review Boards (IRBs). All protocols followed local ethics recommendations and informed consent was obtained when required.
COVID-19 disease severity was assessed in accordance with the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia. The term life-threatening COVID-19 pneumonia describes pneumonia in patients with critical disease, whether pulmonary, with mechanical ventilation [continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), intubation, or high-flow oxygen], septic shock, or damage to any other organ requiring admission in the intensive care unit (ICU). The individuals with asymptomatic or mild SARS-CoV-2 infection were individuals infected with SARS-CoV-2 who remained asymptomatic or developed mild, self-healing, ambulatory disease with no evidence of pneumonia. The healthy controls were individuals who had not been exposed to SARS-CoV-2.
Plasma and serum samples from the patients and controls were frozen at −20°C immediately after collection. The fluid-phase LIPS assay was used to determine the levels of antibodies against the SARS-CoV-2 nucleoprotein and spike protein, as has been previously described (
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