Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NK Cells Treatment for COVID-19

NCT04280224

Novel Coronavirus Pneumonia

COMPLETED PHASE1

Hyperimmune Plasma in Patients With COVID-19 Severe Infection

NCT04385043

COVID-19

UNKNOWN PHASE2/PHASE3

Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection

NCT04362865

COVID-19

COMPLETED

A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19

NCT04324996

COVID-19

UNKNOWN PHASE1/PHASE2

COVID-2019 Vaccine Immune Response Base on Single Cell Multi-Omics

NCT04871932

Immune System and Related Disorders

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

2019-nCoV Immunoglobulin of Cured Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Immunoglobulin of cured patients

Group Type EXPERIMENTAL

Immunoglobulin of cured patients

Intervention Type DRUG

0.2g/kg, ivdrip, once a day, for 3 days

Control group

γ-Globulin

Group Type PLACEBO_COMPARATOR

γ-Globulin

Intervention Type DRUG

0.2g/kg, ivdrip, once a day, for 3 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immunoglobulin of cured patients

0.2g/kg, ivdrip, once a day, for 3 days

Intervention Type DRUG

γ-Globulin

0.2g/kg, ivdrip, once a day, for 3 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Volunteers who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe 2019-nCoV pneumonia:

1. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
2. Lung involvement confirmed with pulmonary CT scan.
3. At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.

Exclusion Criteria

1. Viral pneumonia with other viruses besides 2019-nCoV.
2. Patients are not suitable for immunoglobulin therapy.
3. Participation in other studies.
4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No