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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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ClinicalTrials.gov Identifier: NCT05675943
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing Boren Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematological Disorders COVID-19 Biological: Anti-COVID-19 Antibody SA55 for Injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-COVID-19 Antibody SA55 for Injection
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time when the subject has nucleic acid and the antigen test continues to turn negative [ Time Frame: 21 days post intramuscular injection ]

Secondary Outcome Measures :
  1. Proportion of patients with negative persistent nucleic acid test（NAT）（key secondary endpoint） [ Time Frame: 21 days post intramuscular injection ]
  2. Change of CT value [ Time Frame: 21 days post intramuscular injection ]
  3. Proportion of Subjects Progressing to Severe/Critical [ Time Frame: 21 days post intramuscular injection ]
  4. Proportion of subjects who died from any cause [ Time Frame: 21 days post intramuscular injection ]
  5. Proportion of subjects admitted to ICU [ Time Frame: 21 days post intramuscular injection ]
  6. Number of days a case was admitted to the ICU [ Time Frame: 21 days post intramuscular injection ]
  7. Time of subject's shock correction [ Time Frame: 21 days post intramuscular injection ]
  8. Proportion of subjects requiring oxygen therapy [ Time Frame: 21 days post intramuscular injection ]
  9. Proportion of subjects requiring non-invasive ventilation [ Time Frame: 21 days post intramuscular injection ]
  10. Proportion of subjects requiring mechanical ventilation [ Time Frame: 21 days post intramuscular injection ]
  11. Days of subject's hospitalization from dosing [ Time Frame: 21 days post intramuscular injection ]
  12. Proportion of subjects with severe/critical illness or all-cause death related to COVID-19 [ Time Frame: 21 days post intramuscular injection ]
  13. The incidence of AEs [ Time Frame: 21 days post intramuscular injection ]
  14. The incidence of SAEs [ Time Frame: 21 days post intramuscular injection ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05675943


Contacts
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Contact: Jing Pan +8618911067969 panj@borenhospital.com

Locations
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China, Beijing
Beijing Boren Hospital Recruiting
Beijing, Beijing, China, 100070
Contact: Jing Pan, MD/PhD    +8618911067969    panj@borenhospital.com   
Sponsors and Collaborators
Beijing Boren Hospital
More Information
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Responsible Party: Beijing Boren Hospital
ClinicalTrials.gov Identifier: NCT05675943    
Other Study ID Numbers: PRO-SA55-0004
First Posted: January 9, 2023    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Boren Hospital:
Covid-19
Hematological Disorders
Monoclonal antibody
Additional relevant MeSH terms:
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COVID-19
Hematologic Diseases
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs