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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05675943
Other study ID # PRO-SA55-0004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date May 31, 2024

Study information

Verified date March 2023
Source Beijing Boren Hospital
Contact Jing Pan
Phone +8618911067969
Email panj@borenhospital.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date May 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 75 Years
Eligibility Inclusion Criteria: Subjects in this study must meet all of the following criteria: 1. 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; 2. 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; 3. 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%; 4. 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; 5. 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: 1. Those who are known to be allergic to the test drug and any component in the preparation, or other similar drugs; 2. Complications requiring surgery within 7 days, or complication considered life-threatening within 28 days; 3. Received treatment with SARS-CoV-2 neutralizing antibody drugs before screening; 4. Convalescent plasma from recovered patients before screening; 5. Patients who took anti-SARS-CoV-2 drugs within 48 hours before enrollment, including but not limited to Paxlovid (Nirmatrelvir/Ritonavir), Azvudine, Molnupiravir, etc. 6. On the day of enrollment, meet the diagnostic criteria for severe/critical new coronavirus pneumonia; 7. Suspected to have been combined with active bacteria, fungi, viruses or other infections other than the new coronavirus; 8. Those who plan to become pregnant, are pregnant, or are breastfeeding; 9. 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; 10. Suffering from severe neurological diseases (epilepsy, convulsions or convulsions) or mental illness, with a family history of mental illness; 11. 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. ); 12. Other conditions that the researcher believes are not suitable for participating in this study due to various reasons.

Study Design


Intervention

Biological:
Anti-COVID-19 Antibody SA55 for Injection
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.

Locations

Country Name City State
China Beijing Boren Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Boren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time when the subject has nucleic acid and the antigen test continues to turn negative 21 days post intramuscular injection
Secondary Proportion of patients with negative persistent nucleic acid test(NAT)(key secondary endpoint) 21 days post intramuscular injection
Secondary Change of CT value 21 days post intramuscular injection
Secondary Proportion of Subjects Progressing to Severe/Critical 21 days post intramuscular injection
Secondary Proportion of subjects who died from any cause 21 days post intramuscular injection
Secondary Proportion of subjects admitted to ICU 21 days post intramuscular injection
Secondary Number of days a case was admitted to the ICU 21 days post intramuscular injection
Secondary Time of subject's shock correction 21 days post intramuscular injection
Secondary Proportion of subjects requiring oxygen therapy 21 days post intramuscular injection
Secondary Proportion of subjects requiring non-invasive ventilation 21 days post intramuscular injection
Secondary Proportion of subjects requiring mechanical ventilation 21 days post intramuscular injection
Secondary Days of subject's hospitalization from dosing 21 days post intramuscular injection
Secondary Proportion of subjects with severe/critical illness or all-cause death related to COVID-19 21 days post intramuscular injection
Secondary The incidence of AEs 21 days post intramuscular injection
Secondary The incidence of SAEs 21 days post intramuscular injection
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