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Human COVID-19 Immunoglobulin (COVID-HIG) Therapy for COVID-19 Patients

NCT05173441 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-01-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Human COVID-19 immunoglobulin (pH4) for intravenous injection

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute.

DRUG

Placebo

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute

Sponsors & Collaborators

  • China National Biotec Group Company Limited

    collaborator INDUSTRY

  • Beijing Tiantan Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nawal Al Kaabi, MBBA · Sheikh Khalifa Medical City, SEHA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2023-06-20
Completion
2023-11-30

Countries

  • United Arab Emirates

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173441 on ClinicalTrials.gov