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

Primary Purpose

Hematological Disorders, COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anti-COVID-19 Antibody SA55 for Injection
Sponsored by
Beijing Boren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Disorders focused on measuring Covid-19, Hematological Disorders, Monoclonal antibody

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Boren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anti-COVID-19 Antibody SA55 for Injection

Placebo

Arm Description

Anti-COVID-19 Antibody SA55 for Injection

Anti-COVID-19 Antibody SA55 for Injection administered intramuscular

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with negative persistent nucleic acid test(NAT)(key secondary endpoint)
Change of CT value
Proportion of Subjects Progressing to Severe/Critical
Proportion of subjects who died from any cause
Proportion of subjects admitted to ICU
Number of days a case was admitted to the ICU
Time of subject's shock correction
Proportion of subjects requiring oxygen therapy
Proportion of subjects requiring non-invasive ventilation
Proportion of subjects requiring mechanical ventilation
Days of subject's hospitalization from dosing
Proportion of subjects with severe/critical illness or all-cause death related to COVID-19
The incidence of AEs
The incidence of SAEs

Full Information

First Posted
January 6, 2023
Last Updated
April 13, 2023
Sponsor
Beijing Boren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05675943
Brief Title
Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematological Disorders Who Are Persistently Positive for COVID-19
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Boren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Disorders, COVID-19
Keywords
Covid-19, Hematological Disorders, Monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-COVID-19 Antibody SA55 for Injection
Arm Type
Experimental
Arm Description
Anti-COVID-19 Antibody SA55 for Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Anti-COVID-19 Antibody SA55 for Injection administered intramuscular
Intervention Type
Biological
Intervention Name(s)
Anti-COVID-19 Antibody SA55 for Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time when the subject has nucleic acid and the antigen test continues to turn negative
Time Frame
21 days post intramuscular injection
Secondary Outcome Measure Information:
Title
Proportion of patients with negative persistent nucleic acid test(NAT)(key secondary endpoint)
Time Frame
21 days post intramuscular injection
Title
Change of CT value
Time Frame
21 days post intramuscular injection
Title
Proportion of Subjects Progressing to Severe/Critical
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects who died from any cause
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects admitted to ICU
Time Frame
21 days post intramuscular injection
Title
Number of days a case was admitted to the ICU
Time Frame
21 days post intramuscular injection
Title
Time of subject's shock correction
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects requiring oxygen therapy
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects requiring non-invasive ventilation
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects requiring mechanical ventilation
Time Frame
21 days post intramuscular injection
Title
Days of subject's hospitalization from dosing
Time Frame
21 days post intramuscular injection
Title
Proportion of subjects with severe/critical illness or all-cause death related to COVID-19
Time Frame
21 days post intramuscular injection
Title
The incidence of AEs
Time Frame
21 days post intramuscular injection
Title
The incidence of SAEs
Time Frame
21 days post intramuscular injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Pan
Phone
+8618911067969
Email
panj@borenhospital.com
Facility Information:
Facility Name
Beijing Boren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Pan, MD/PhD
Phone
+8618911067969
Email
panj@borenhospital.com

12. IPD Sharing Statement

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

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