Hematological DisordersNCT05675943
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 study testing Anti-COVID-19 Antibody SA55 for Injection in people with Hematological Disorders and COVID-19, run by Beijing Boren Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Hematological Disorders, COVID-19
- What is being tested?
- Anti-COVID-19 Antibody SA55 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2023to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hematological Disorders, COVID-19
- Being tested
- Anti-COVID-19 Antibody SA55 for Injection
- Keywords
- Covid-19, Hematological Disorders, Monoclonal antibody
- Medical subject headings
- Hematologic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-COVID-19 Antibody SA55 for InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-COVID-19 Antibody SA55 for Injection | Experimental | Anti-COVID-19 Antibody SA55 for Injection Receives: Biological: Anti-COVID-19 Antibody SA55 for Injection |
| Placebo | Placebo comparator | Anti-COVID-19 Antibody SA55 for Injection administered intramuscular Receives: Biological: Anti-COVID-19 Antibody SA55 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time when the subject has nucleic acid and the antigen test continues to turn negative
Measured: 21 days post intramuscular injection
Secondary outcomes (14)
Proportion of patients with negative persistent nucleic acid test（NAT）（key secondary endpoint）
Measured: 21 days post intramuscular injection
Change of CT value
Measured: 21 days post intramuscular injection
Proportion of Subjects Progressing to Severe/Critical
Measured: 21 days post intramuscular injection
Proportion of subjects who died from any cause
Measured: 21 days post intramuscular injection
Proportion of subjects admitted to ICU
Measured: 21 days post intramuscular injection
Number of days a case was admitted to the ICU
Measured: 21 days post intramuscular injection
Time of subject's shock correction
Measured: 21 days post intramuscular injection
Proportion of subjects requiring oxygen therapy
Measured: 21 days post intramuscular injection
Proportion of subjects requiring non-invasive ventilation
Measured: 21 days post intramuscular injection
Proportion of subjects requiring mechanical ventilation
Measured: 21 days post intramuscular injection
Days of subject's hospitalization from dosing
Measured: 21 days post intramuscular injection
Proportion of subjects with severe/critical illness or all-cause death related to COVID-19
Measured: 21 days post intramuscular injection
The incidence of AEs
Measured: 21 days post intramuscular injection
The incidence of SAEs
Measured: 21 days post intramuscular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start12 Jan 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675943
- Sponsor's protocol ID
- PRO-SA55-0004
- Status last verified
- May 2025
- First submitted
- 6 Jan 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05675943
- Acronym / sponsor ID
- PRO-SA55-0004
- Conditions
- Hematological Disorders, COVID-19
- Keywords
- Covid-19, Hematological Disorders, Monoclonal antibody
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-COVID-19 Antibody SA55 for Injection | Experimental | Biological: Anti-COVID-19 Antibody SA55 for InjectionAnti-COVID-19 Antibody SA55 for Injection |
| Placebo | Placebo comparator | Biological: Anti-COVID-19 Antibody SA55 for InjectionAnti-COVID-19 Antibody SA55 for Injection administered intramuscular |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-COVID-19 Antibody SA55 for InjectionAfter 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. | Biological | Anti-COVID-19 Antibody SA55 for Injection, Placebo |
Primary outcome
Time when the subject has nucleic acid and the antigen test continues to turn negative
Time frame: 21 days post intramuscular injection
14 secondary outcomes
Proportion of patients with negative persistent nucleic acid test（NAT）（key secondary endpoint）
Time frame: 21 days post intramuscular injection
Change of CT value
Time frame: 21 days post intramuscular injection
Proportion of Subjects Progressing to Severe/Critical
Time frame: 21 days post intramuscular injection
Proportion of subjects who died from any cause
Time frame: 21 days post intramuscular injection
Proportion of subjects admitted to ICU
Time frame: 21 days post intramuscular injection
Number of days a case was admitted to the ICU
Time frame: 21 days post intramuscular injection
Time of subject's shock correction
Time frame: 21 days post intramuscular injection
Proportion of subjects requiring oxygen therapy
Time frame: 21 days post intramuscular injection
Proportion of subjects requiring non-invasive ventilation
Time frame: 21 days post intramuscular injection
Proportion of subjects requiring mechanical ventilation
Time frame: 21 days post intramuscular injection
Days of subject's hospitalization from dosing
Time frame: 21 days post intramuscular injection
Proportion of subjects with severe/critical illness or all-cause death related to COVID-19
Time frame: 21 days post intramuscular injection
The incidence of AEs
Time frame: 21 days post intramuscular injection
The incidence of SAEs
Time frame: 21 days post intramuscular injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-COVID-19 Antibody SA55 for Injection in people with Hematological Disorders and COVID-19, run by Beijing Boren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time when the subject has nucleic acid and the antigen test continues to turn negative (time frame: 21 days post intramuscular injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.