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

NCT04264858 | Unknown DMC

• 1 other identifier: WuhanUH-2019 nCoV-Ig
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

2019-nCoV; Immunoglobulin of Cured Patients

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Improvement (TTCI)

  TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.

  up to 28 days

Secondary Outcomes (10)

• Clinical status assessed by the ordinal scale

  up to 28 days

• The differences in oxygen intake methods

  up to 28 days

• Duration (days) of supplemental oxygenation

  up to 28 days

• Duration (days) of mechanical ventilation

  up to 28 days

• The mean PaO2/FiO2

  up to 28 days

Study Arms (2)

Treatment group

EXPERIMENTAL

Immunoglobulin of cured patients

Drug: Immunoglobulin of cured patients

Control group

PLACEBO COMPARATOR

γ-Globulin

Drug: γ-Globulin

Interventions

Immunoglobulin of cured patients DRUG

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

Treatment group

γ-Globulin DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers who have understood and signed the informed consent;
• Age ≥18 years, gender unlimited;
• Patients diagnosed with acute severe 2019-nCoV pneumonia:
• Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
• Lung involvement confirmed with pulmonary CT scan.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of cardiology, Wuhan Union Hospital, China

Study Record Dates

• First Submitted: February 8, 2020
• First Posted: February 11, 2020
• Study Start: March 17, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)