Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematologic… (NCT05675943) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematological Disorders Who Are Persistently Positive for COVID-19
China31 participantsStarted 2023-01-12
Plain-language summary
This study is a multicenter, randomized, single-blind, placebo-controlled clinical trial to evaluate the effectiveness and safety of Anti-COVID-19 Antibody SA55 for Injection in patients with hematological malignancies. This study consists of two stages. In the first stage, 8 subjects aged 18-75 were recruited for safety assessment, including the monitoring of clinical test indicators and adverse events. After confirming the preliminary safety results of the first stage, we plan to recruit 160 COVID-19 patients with hematologic disorders aged 1-75 years old and randomly divided into the SA55 group and the placebo group with a ratio of 3:1. Basic information and laboratory tests will be collected during the whole study, and the occurrence of adverse events and SAEs of all subjects were collected.
Who can participate
Age range1 Year – 75 Years
SexALL
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Inclusion 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 are known to be allergic to the test drug and any component in the preparation, or other similar drugs;
✕
What they're measuring
1
Time when the subject has nucleic acid and the antigen test continues to turn negative
. 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;