2. Patients and Methods
2.1 Patients
The study enrolled 20 patients with PNH infected SARS-CoV-2 Omicron prospectively registered in the Chinese Eastern Collaboration Group of Anemia (ChiCTR2100050945), which was conducted by four centers: the First Affiliated Hospital with Nanjing Medical University (Nanjing, China), the second people’s hospital of Lianyungang (Lianyungang, China), Wuxi People’s Hospital (Wuxi, China) and Funing People’s Hospital (Funing, China) from December 2022 to February 2023. Patients signed informed consent. The study was conducted according the Declaration of Helsinki and approved by the hospital ethics committee.
2.2 Diagnostic criteria
All the patients developed fever, cough, nasal congestion, sore throat, or other uncomfortable symptoms. Reverse transcription polymerase chain reaction (RT-PCR) or antigen testing for SARS-Cov-2 was positive.
High disease activity (HDA) was defined as evidence of hemolysis (elevated lactate dehydrogenase [LDH]≥1.5 times upper limit of normal [ULN]) and a history of at least 1 of the following signs or symptoms— fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia (hemoglobin < 100 g/L), MAVEs (including TEs), dysphagia, or erectile dysfunction[19].
2.3 Methods
A collection on 20 patients with PNH registered in 4 centers is to evaluate the occurrence and clinical characteristics of SARS-CoV-2 infection, and the efficacy of eculizumab.