Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05675943
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-01-06
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
Sponsor:
Beijing Boren Hospital
Organization:
Beijing Boren Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 31 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None