A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in the Treatment of Patients With Hematological Disorders Who Are Persistently Positive for the Covid-19

Beijing Boren Hospital1 site in 1 country31 target enrollmentJanuary 12, 2023

ConditionsHematological Disorders COVID-19

InterventionsAnti-COVID-19 Antibody SA55 for Injection

DrugsAnti-COVID-19 Antibody SA55 for Injection

Overview

Phase: N/A
Intervention: Anti-COVID-19 Antibody SA55 for Injection
Conditions: Hematological Disorders
Sponsor: Beijing Boren Hospital
Enrollment: 31
Locations: 1
Primary Endpoint: Time when the subject has nucleic acid and the antigen test continues to turn negative
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 12, 2023

End Date

April 3, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Boren Hospital

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Anti-COVID-19 Antibody SA55 for Injection

Intervention: Anti-COVID-19 Antibody SA55 for Injection

Placebo

Anti-COVID-19 Antibody SA55 for Injection administered intramuscular

Intervention: Anti-COVID-19 Antibody SA55 for Injection

Outcomes

Primary Outcomes

Time when the subject has nucleic acid and the antigen test continues to turn negative

Time Frame: 21 days post intramuscular injection

Secondary Outcomes

Proportion of subjects requiring oxygen therapy(21 days post intramuscular injection)
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)
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 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)