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Clinical Trial Summary

A randomized, double-blind, placebo-controlled phase II exploratory clinical trial to evaluate the efficacy and safety of Human COVID-19 immunoglobulin (pH4) for intravenous injection (COVID-HIG) in the treatment of patients with COVID-19.


Clinical Trial Description

Eligible adault patients with confirmed COVID-19 will be randomized 1:1:1 to receive intravenous injections of High-dose COVID-HIG, Low-dose COVID-HIG or Placebo ( 0.9% sodium chloride injection). Patients in each arm will receive continued standard of care (SOC) therapy. The primary efficacy end point is the median time to clinical improvement (defined as clinical improvement of at least 2 points from baseline on the 7-point ordinal scale) observed from 0 to 28 days after the first administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05173441
Study type Interventional
Source Beijing Tiantan Biological Products Co., Ltd.
Contact YunKai Yang, Prof
Phone +86-13601126881
Email yangyunkai@sinopharm.com
Status Not yet recruiting
Phase Phase 2
Start date December 30, 2021
Completion date November 30, 2023

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