NCT05675943

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Disorders
• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-12
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2023-01-09
• Last updated: 2025-05-18

Locations

1 site across 1 country: China