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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Hematological Disorders
• Intervention / Treatment: Biological: Anti-COVID-19 Antibody SA55 for Injection

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Boren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-COVID-19 Antibody SA55 for Injection	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.
Placebo Comparator: Placebo; Anti-COVID-19 Antibody SA55 for Injection administered intramuscular	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time when the subject has nucleic acid and the antigen test continues to turn negative	21 days post intramuscular injection

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
Change of CT value	21 days post intramuscular injection
Proportion of patients with negative persistent nucleic acid test（NAT）（key secondary endpoint）	21 days post intramuscular injection

Collaborators and Investigators

• Sponsor: Beijing Boren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Covid-19; Hematological Disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Disease; Hematologic Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: PRO-SA55-0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No