NCT04261426

Brief Summary

In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 6, 2020

Last Update Submit

February 6, 2020

Conditions

2019-nCoV

Outcome Measures

Primary Outcomes (3)

  • Clinical improvement based on the 7-point scale

    A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).

    28 days after randomization

  • Lower Murray lung injury score

    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.

    7 days after randomization

  • Lower Murray lung injury score

    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.

    14 days after randomization

Secondary Outcomes (8)

  • 28-day mortality

    Measured from Day 0 through Day 28

  • Duration of mechanical ventilation

    Measured from Day 0 through Day 28

  • Duration of hospitalization

    Measured from Day 0 through Day 28

  • Proportion of patients with negative RT-PCR results

    7 and 14 days after randomization

  • Proportion of patients in each category of the 7-point scale

    7,14 and 28 days after randomization

  • +3 more secondary outcomes

Study Arms (2)

IVIG therapy+ standard care

EXPERIMENTAL
Drug: Intravenous ImmunoglobulinOther: Standard care

Standard care

PLACEBO COMPARATOR
Other: Standard care

Interventions

Intravenous ImmunoglobulinDRUG

IVIG 0.5g/kg/d for 5 days

Also known as: Human Immunoglobulin (pH4) for Intravenous Injection
IVIG therapy+ standard care
Standard careOTHER

Standard care

IVIG therapy+ standard careStandard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged \>=18years old;
  • Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
  • The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
  • Meet any of the following criteria for severe or critical ill conditions:
  • Respiratory rate \>=30/min; or
  • Rest SPO2\<=90%; or
  • PaO2/FiO2\<=300mmHg; or
  • Respiratory failure and needs mechanical ventilation; or
  • Shock occurs; or
  • Multiple organ failure and needs ICU monitoring;
  • Sign the Informed Consent Form on a voluntary basis.

You may not qualify if:

  • Exist of other evidences that can explain pneumonia including but not limited to:
  • influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;
  • Allergy to Intravenous Immunoglobulin or its preparation components;
  • Patients with selective IgA deficiency
  • Women who are pregnant or breast-feeding;
  • Researchers consider unsuitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Immunoglobulins, IntravenousStandard of Care

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Taisheng Li

CONTACT

010-69155086litsh@263.net

Wei Cao

CONTACT

wcao_pumch@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Infectious Disease, Principal Investigator

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 7, 2020

Study Start

February 10, 2020

Primary Completion

April 30, 2020

Study Completion

June 30, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02