Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematological Disorders Who Are Persistently Positive for COVID-19

Inclusion criteria

Subjects in this study must meet all of the following criteria:

• Male or female patients with hematological malignancies who are in stable condition or with bone marrow failure disorders and aged from 1 to 75 years old on the day of enrollment;
• On the day of enrollment, the subject was judged to be positive for Covid-19 nucleic acid/antigen for more than 10 days without turning negative or had turned negative but recovered positive again after 10 days;
• On the day of enrollment, patients who have received CAR T-cell therapy, corticosteroids for a long time or other immuno-suppressive drugs, with the proportion of peripheral blood B cells is less than 2%;
• Subjects (men and women with childbearing potential) and their sexual partners voluntarily take effective contraceptive measures from 4 weeks before screening to 3 months after the last dose of the test drug, and have no plan to donate sperm or eggs;
• Subjects voluntarily participate in the trial and sign the informed consent form before the study begins.

Exclusion criteria

Those who meet any of the following conditions will be excluded:

• Those who are known to be allergic to the test drug and any component in the preparation, or other similar drugs;
• Complications requiring surgery within 7 days, or complication considered life-threatening within 28 days;
• Received treatment with SARS-CoV-2 neutralizing antibody drugs before screening;
• Convalescent plasma from recovered patients before screening;
• Patients who took anti-SARS-CoV-2 drugs within 48 hours before enrollment, including but not limited to Paxlovid (Nirmatrelvir/Ritonavir), Azvudine, Molnupiravir, etc.
• On the day of enrollment, meet the diagnostic criteria for severe/critical new coronavirus pneumonia;
• Suspected to have been combined with active bacteria, fungi, viruses or other infections other than the new coronavirus;
• Those who plan to become pregnant, are pregnant, or are breastfeeding;
• Participated in clinical trials of SARS-CoV-2 neutralizing antibody drugs within 180 days before screening or participated in clinical trials of other drugs or medical devices within 4 weeks before screening;
• Suffering from severe neurological diseases (epilepsy, convulsions or convulsions) or mental illness, with a family history of mental illness;
• Suffering from other serious diseases that are not controlled, such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, endocrine system diseases; or other diseases that the researchers judge are not suitable for participating in the study (such as currently uncontrolled autoimmune diseases, etc. );
• Other conditions that the researcher believes are not suitable for participating in this study due to various reasons.