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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-COVID-19 Antibody SA55 for Injection | Experimental | Anti-COVID-19 Antibody SA55 for Injection |
|
| Placebo | Placebo Comparator | Anti-COVID-19 Antibody SA55 for Injection administered intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-COVID-19 Antibody SA55 for Injection | Biological | After the subjects are successfully screened, according to the group they belong to, they will be given the corresponding drug by intramuscular injection once (the dose of SA55 injection for subjects 40kg and above in the test group is 600mg (4ml), and the dose of SA55 injection for subjects in the test group below 40kg is 300mg (2ml), the subjects in the placebo group who are 40kg and above are injected with 4ml of placebo, and those in the test group under 40kg are injected with 2ml of placebo.The injection is allowed in both deltoid muscle of the upper arm or the buttocks muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Time when the subject has nucleic acid and the antigen test continues to turn negative | 21 days post intramuscular injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with negative persistent nucleic acid test(NAT)(key secondary endpoint) | 21 days post intramuscular injection | |
| Change of CT value | 21 days post intramuscular injection | |
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Inclusion Criteria:
Subjects in this study must meet all of the following criteria:
Exclusion Criteria:
Those who meet any of the following conditions will be excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Boren Hospital | Beijing | Beijing Municipality | 100070 | China |
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|
| Proportion of Subjects Progressing to Severe/Critical |
| 21 days post intramuscular injection |
| Proportion of subjects who died from any cause | 21 days post intramuscular injection |
| Proportion of subjects admitted to ICU | 21 days post intramuscular injection |
| Number of days a case was admitted to the ICU | 21 days post intramuscular injection |
| Time of subject's shock correction | 21 days post intramuscular injection |
| Proportion of subjects requiring oxygen therapy | 21 days post intramuscular injection |
| Proportion of subjects requiring non-invasive ventilation | 21 days post intramuscular injection |
| Proportion of subjects requiring mechanical ventilation | 21 days post intramuscular injection |
| Days of subject's hospitalization from dosing | 21 days post intramuscular injection |
| Proportion of subjects with severe/critical illness or all-cause death related to COVID-19 | 21 days post intramuscular injection |
| The incidence of AEs | 21 days post intramuscular injection |
| The incidence of SAEs | 21 days post intramuscular injection |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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